Trial Outcomes & Findings for A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis (NCT NCT03210961)
NCT ID: NCT03210961
Last Updated: 2020-03-31
Results Overview
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure \[BP\] and supine pulse rate \[PR\]) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided. Number of participants in PBO SAD cohorts = number of participants in \[PBO SAD (3mg, 10mg)\] cohorts + number of participants in \[PBO SAD -\> PBO QD MAD\] cohorts.
COMPLETED
PHASE1
109 participants
Baseline up to Day 8
2020-03-31
Participant Flow
A total of 208 potential participants were screened after signing an informed consent form, of whom 109 participants were randomized to receive study treatment.
Participant milestones
| Measure |
Placebo (PBO) SAD (3 Milligrams [mg], 10 mg)
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, or 10 mg single dose (SD) cohort in fasted state.
|
PBO SAD Followed by (->) PBO QD MAD
During SAD period (Period 1), healthy participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg SD cohort, respectively, in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In MAD period (Period 2), these participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg once daily (QD) cohort, respectively, for 10 days with standard meal.
|
PBO QD MAD Japanese Cohort (JP)
During the MAD period (Period 2), Japanese healthy participants received placebo matching PF-06826647 400 mg QD MAD JP cohort with standard meal. MAD period duration was 28 days.
|
PBO Twice Daily (BID)
During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
|
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state. SAD period duration was 8 days.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state. SAD period duration was 8 days.
|
PF-06826647 30 mg SAD -> 30 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
|
PF-06826647 100 mg SAD -> 100 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants 4 received PF-06826647 100 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
|
PF-06826647 400 mg SAD -> 400 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days. SAD period duration was 8 days and MAD period duration was 28 days.
|
PF-06826647 1600 mg SAD -> 1200 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
|
PF-06826647 200 mg BID
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
PBO QD Psoriasis Cohort (PSO)
In the psoriasis placebo cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD cohort, respectively, for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
|
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
|
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
1
|
2
|
6
|
6
|
8
|
7
|
8
|
6
|
7
|
5
|
14
|
15
|
11
|
|
Overall Study
COMPLETED
|
4
|
9
|
1
|
1
|
6
|
6
|
7
|
7
|
8
|
6
|
6
|
5
|
12
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
2
|
4
|
2
|
Reasons for withdrawal
| Measure |
Placebo (PBO) SAD (3 Milligrams [mg], 10 mg)
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, or 10 mg single dose (SD) cohort in fasted state.
|
PBO SAD Followed by (->) PBO QD MAD
During SAD period (Period 1), healthy participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg SD cohort, respectively, in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In MAD period (Period 2), these participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg once daily (QD) cohort, respectively, for 10 days with standard meal.
|
PBO QD MAD Japanese Cohort (JP)
During the MAD period (Period 2), Japanese healthy participants received placebo matching PF-06826647 400 mg QD MAD JP cohort with standard meal. MAD period duration was 28 days.
|
PBO Twice Daily (BID)
During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
|
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state. SAD period duration was 8 days.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state. SAD period duration was 8 days.
|
PF-06826647 30 mg SAD -> 30 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
|
PF-06826647 100 mg SAD -> 100 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants 4 received PF-06826647 100 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
|
PF-06826647 400 mg SAD -> 400 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days. SAD period duration was 8 days and MAD period duration was 28 days.
|
PF-06826647 1600 mg SAD -> 1200 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
|
PF-06826647 200 mg BID
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
PBO QD Psoriasis Cohort (PSO)
In the psoriasis placebo cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD cohort, respectively, for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
|
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
|
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
No Longer Meets Eligibility Criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
2
|
2
|
0
|
Baseline Characteristics
A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo (PBO) SAD (3 mg, 10 mg)
n=4 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, or 10 mg single dose (SD) cohort in fasted state.
|
PBO SAD Followed by (->) PBO QD MAD
n=9 Participants
During SAD period (Period 1), healthy participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg SD cohort, respectively, in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In MAD period (Period 2), these participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg once daily (QD) cohort, respectively, for 10 days with standard meal.
|
PBO QD MAD Japanese Cohort (JP)
n=1 Participants
During the MAD period (Period 2), Japanese healthy participants received placebo matching PF-06826647 400 mg QD MAD JP cohort with standard meal. MAD period duration was 28 days.
|
PBO BID
n=2 Participants
During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state. SAD period duration was 8 days.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state. SAD period duration was 8 days.
|
PF-06826647 30 mg SAD -> 30 mg QD MAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
|
PF-06826647 100 mg SAD -> 100 mg QD MAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants 4 received PF-06826647 100 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
|
PF-06826647 400 mg SAD -> 400 mg QD MAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days. SAD period duration was 8 days and MAD period duration was 28 days.
|
PF-06826647 1600 mg SAD -> 1200 mg QD MAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
|
PF-06826647 200 mg BID
n=7 Participants
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
|
PF-06826647 400 mg QD MAD JP
n=5 Participants
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
PBO QD Psoriasis Cohort (PSO)
n=14 Participants
In the psoriasis placebo cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD cohort, respectively, for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
|
PF-06826647 400 mg QD PSO
n=15 Participants
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
|
PF-06826647 100 mg QD PSO
n=11 Participants
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
17 Participants
n=135 Participants
|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 12.23 • n=5 Participants
|
42.2 years
STANDARD_DEVIATION 10.84 • n=7 Participants
|
34.0 years
STANDARD_DEVIATION NA • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 4.95 • n=4 Participants
|
44.3 years
STANDARD_DEVIATION 11.47 • n=21 Participants
|
40.2 years
STANDARD_DEVIATION 10.30 • n=8 Participants
|
40.5 years
STANDARD_DEVIATION 11.64 • n=8 Participants
|
36.9 years
STANDARD_DEVIATION 7.40 • n=24 Participants
|
37.5 years
STANDARD_DEVIATION 8.23 • n=42 Participants
|
31.2 years
STANDARD_DEVIATION 5.00 • n=42 Participants
|
37.4 years
STANDARD_DEVIATION 9.27 • n=42 Participants
|
39.8 years
STANDARD_DEVIATION 5.40 • n=42 Participants
|
38.3 years
STANDARD_DEVIATION 13.25 • n=36 Participants
|
40.9 years
STANDARD_DEVIATION 11.62 • n=36 Participants
|
39.0 years
STANDARD_DEVIATION 13.39 • n=24 Participants
|
39.0 years
STANDARD_DEVIATION 10.53 • n=135 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
15 Participants
n=36 Participants
|
11 Participants
n=24 Participants
|
106 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
40 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
11 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
69 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
17 Participants
n=135 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
11 Participants
n=24 Participants
|
69 Participants
n=135 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 8Population: The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure \[BP\] and supine pulse rate \[PR\]) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided. Number of participants in PBO SAD cohorts = number of participants in \[PBO SAD (3mg, 10mg)\] cohorts + number of participants in \[PBO SAD -\> PBO QD MAD\] cohorts.
Outcome measures
| Measure |
PBO SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)
Supine pulse rate Value >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)
Supine systolic BP Value <90mmHg
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)
Supine systolic BP Chg ≥30 mmHg increase
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)
Supine systolic BP Chg ≥30mmHg decrease
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)
Supine diastolic BP Value <50 mmHg
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)
Supine diastolic BP Change (Chg) ≥20 mmHg increase
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)
Supine diastolic BP Chg ≥20 mmHg decrease
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)
Supine pulse rate Value <40 beats per minute (bpm)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 28Population: The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure and supine pulse rate) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
Outcome measures
| Measure |
PBO SAD
n=9 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=2 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
n=5 Participants
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)
Supine pulse rate Value < 40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)
Supine diastolic BP Value < 50 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)
Supine diastolic BP Chg ≥ 20 mmHg increase
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)
Supine diastolic BP Chg ≥ 20 mmHg decrease
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)
Supine pulse rate Value > 120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)
Supine systolic blood pressure Value < 90 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)
Supine systolic BP Chg ≥ 30 mmHg increase
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)
Supine systolic BP Chg ≥ 30 mmHg decrease
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 56Population: The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure and supine pulse rate) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
Outcome measures
| Measure |
PBO SAD
n=14 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=15 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=11 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Supine pulse rate Value < 40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Supine pulse rate Value > 120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Supine systolic BP Value < 90 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Supine systolic BP Chg ≥ 30 mmHg increase
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Supine systolic BP Chg ≥ 30 mmHg decrease
|
6 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Supine diastolic blood pressure Value < 50 mmHg
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Supine diastolic BP Chg ≥ 20 mmHg increase
|
0 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Supine diastolic BP Chg ≥ 20 mmHg decrease
|
6 Participants
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 8Population: The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision. Number of participants in PBO SAD cohorts = number of participants in \[PBO SAD (3mg, 10mg)\] cohorts + number of participants in \[PBO SAD -\> PBO QD MAD\] cohorts.
Outcome measures
| Measure |
PBO SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
cardiovascular
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
ears
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
eyes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
gastrointestinal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
general appearance
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
head
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
heart
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
lungs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
lymph nodes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
mouth
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
musculoskeletal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
neurological
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
nose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
skin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 28Population: The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Outcome measures
| Measure |
PBO SAD
n=9 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=2 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
n=5 Participants
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
cardiovascular
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
gastrointestinal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
ears
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
general appearance
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
head
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
heart
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
lungs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
eyes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
lymph nodes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
mouth
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
musculoskeletal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
neurological
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
nose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
skin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 56Population: The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Outcome measures
| Measure |
PBO SAD
n=14 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=15 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=11 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
cardiovascular
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
mouth
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
ears at screening
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
ears at Day 28
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
eyes
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
musculoskeletal
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
gastrointestinal
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
neurological
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
nose
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
general appearance
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
head
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
heart
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
lungs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
skin
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
lymph nodes
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 8Population: The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and \<480 millisecond (msec), ≥480 and \<500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and \<60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline \>200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%. Number of participants in PBO SAD cohorts = number of participants in \[PBO SAD (3mg, 10mg)\] cohorts + number of participants in \[PBO SAD -\> PBO QD MAD\] cohorts.
Outcome measures
| Measure |
PBO SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
QRS maximum absolute value ≥140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
QRS maximum increase from baseline ≥50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
QTCF maximum absolute value ≥450 and <480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
QTCF maximum absolute value ≥480 and <500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
QTCF maximum absolute value ≥500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
QTCF maximum increase ≥30 and <60 msec
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
QTCF maximum increase from baseline ≥60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
PR maximum absolute value ≥300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
PR maximum increase from baseline ≥25/50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 28Population: The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and \<480 millisecond (msec), ≥480 and \<500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and \<60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline \>200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
Outcome measures
| Measure |
PBO SAD
n=9 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=2 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
n=5 Participants
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
QTCF maximum absolute value ≥480 and <500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
QTCF maximum absolute value ≥500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
QTCF maximum increase ≥30 and <60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
QTCF maximum increase from baseline ≥60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
PR maximum absolute value ≥300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
PR maximum increase from baseline ≥25/50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
QRS maximum absolute value ≥140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
QRS maximum increase from baseline ≥50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
QTCF maximum absolute value ≥450 and <480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 56Population: The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and \<480 millisecond (msec), ≥480 and \<500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and \<60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline \>200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
Outcome measures
| Measure |
PBO SAD
n=14 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=15 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=11 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
PR maximum absolute value ≥300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
PR maximum increase from baseline ≥25/50%
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
QRS maximum absolute value ≥140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
QRS maximum increase from baseline ≥50%
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
QTCF maximum absolute value ≥450 and <480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
QTCF maximum absolute value ≥480 and <500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
QTCF maximum absolute value ≥500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
QTCF maximum increase ≥30 and <60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
QTCF maximum increase from baseline ≥60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 8Population: The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE. PBO SAD cohorts = \[PBO SAD (3mg, 10mg)\] cohorts + \[PBO SAD -\> PBO QD MAD\] cohorts.
Outcome measures
| Measure |
PBO SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)
Participants with AEs (AC)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)
Participants with AEs (TR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)
Participants with SAEs (AC)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)
Participants with SAEs (TR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)
Participants with severe AEs (AC)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)
Participants with severe AEs (TR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)
Participants withdrew due to AEs (AC)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)
Participants withdrew due to AEs (TR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 28Population: The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
Outcome measures
| Measure |
PBO SAD
n=9 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=2 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
n=5 Participants
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)
Participants with AEs (AC)
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)
Participants with AEs (TR)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)
Participants with SAEs (AC)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)
Participants with SAEs (TR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)
Participants with severe AEs (AC)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)
Participants with severe AEs (TR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)
Participants withdrew due to AEs (AC)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)
Participants withdrew due to AEs (TR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 84Population: The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
Outcome measures
| Measure |
PBO SAD
n=14 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=15 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=11 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)
Participants with AEs (AC)
|
7 Participants
|
12 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)
Participants with AEs (TR)
|
5 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)
Participants with SAEs (AC)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)
Participants with SAEs (TR)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)
Participants with severe AEs (AC)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)
Participants with severe AEs (TR)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)
Participants withdrew due to AEs (AC)
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)
Participants withdrew due to AEs (TR)
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 8Population: The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters for laboratory abnormalities evaluation included: erythrocyte mean corpuscular volume (Ery. MCV), erythrocyte mean corpuscular hemoglobin (Ery. MCH), reticulocytes/erythrocytes (%), limphocytes, eosinophils, bilirubin, aspartate aminotransferase (AST), urate, high-density lipoproteins (HDL) cholesterol, low-density lipoproteins (LDL) cholesterol, triglycerides, cholesterol, ketones, nitrite, leukocyte esterase, epithelial cells, urinalysis-bacteria. Number of participants in PBO SAD cohorts = number of participants in \[PBO SAD (3mg, 10mg)\] cohorts + number of participants in \[PBO SAD -\> PBO QD MAD\] cohorts.
Outcome measures
| Measure |
PBO SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Ery. MCV (femtoliters [fL]) <0.9 × LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Ery. MCH (picograms [pg]) <0.9 × LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Reticulocytes/erythrocytes (%) >1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Limphocytes (10^3/mm^3) <0.8 × LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Eosinophils (10^3/mm^3) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Bilirubin (mg/dL) >1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
AST (U/L) >3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Urate (mg/dL) >1.2 x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
HDL cholesterol (mg/dL) <0.8 × LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
LDL cholesterol (mg/dL) >1.2 x ULN
|
10 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Triglycerides (mg/dL) >1.3 x ULN
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Cholesterol (mg/dL) >1.3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Ketones ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Nitrite ≥1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Leukocyte esterase ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Epithelial cells (/LPF) ≥6
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities (SAD Period)
Urinalysis-bacteria (/HPF) ≥20
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 28Population: The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters and corresponding primary criteria for laboratory abnormalities evaluation included: Ery. MCV \<0.9 × LLN, Ery. Mean corpuscular hemoglobin (Ery. MCH) \<0.9 × LLN or \>1.1 ULN, reticulocytes/erythrocytes (%) \>1.5 × ULN, lymphocytes \<0.8 × LLN or \>1.2 × ULN, neutrophils \<0.8 × LLN, eosinophils \>1.2 × ULN, bilirubin \>1.5 × ULN, urate \>1.2 × ULN, HDL cholesterol \<0.8 × LLN, LDL cholesterol \>1.2 × ULN, triglycerides \>1.3 × ULN, bicarbonate \>1.1 × ULN, cholesterol \>1.3 × ULN, urine glucose ≥1, urine hemoglobin ≥1, nitrite ≥1, leukocyte esterase ≥1, epithelial cells ≥6/LPF, urinalysis-casts \>1/LPF, urinalysis-bacteria \>20/HPF, urine 24 hours creatinine \>1.1 × ULN.
Outcome measures
| Measure |
PBO SAD
n=9 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=2 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
n=5 Participants
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Ery. MCV (fL) <0.9 × LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Ery. MCH (pg) <0.9 × LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Ery. MCH (pg) >1.1 × ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Reticulocytes/erythrocytes (%) >1.5 × ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Lymphocytes (10^3/mm^3) <0.8 × LLN
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Lymphocytes (10^3/mm^3) >1.2 × ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Neutrophils (10^3/mm^3) <0.8 × LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Eosinophils (10^3/mm^3) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Bilirubin (mg/dL) >1.5 x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Urate (mg/dL) >1.2 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
HDL cholesterol (mg/dL) <0.8 × LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
LDL cholesterol (mg/dL) >1.2 x ULN
|
7 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Triglycerides (mg/dL) >1.3 x ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Bicarbonate (mEq/L) >1.1 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
cholesterol (mg/dL) >1.3 x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Urine glucose ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Urine hemoglobin ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Nitrite ≥1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Leukocyte esterase ≥1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Epithelial cells (/LPF) ≥6
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Urinalysis-casts (/LPF) >1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Urinalysis-bacteria (/HPF) >20
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (MAD Period)
Urine 24 hours creatinine (mg/24 hr) >1.1 x ULN
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 56Population: The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters and corresponding primary criteria for laboratory abnormalities evaluation included: reticulocytes/erythrocytes (%) \>1.5 × ULN, lymphocytes \<0.8 × LLN, neutrophils \<0.8 × LLN or \>1.2 × ULN, eosinophils \>1.2 × ULN, bilirubin \>1.5 × ULN, alanine aminotransferase (ALT) \>3.0 × ULN, creatinine \>1.3 × ULN, urate \>1.2 × ULN, HDL cholesterol \<0.8 × LLN, LDL cholesterol \>1.2 × ULN, triglycerides \>1.3 × ULN, potassium \>1.1 × ULN, bicarbonate \>1.1 × ULN, glucose \<0.6 × LLN or \>1.5 × ULN, Creatine Kinase (CK) \>2.0 × ULN, cholesterol \>1.3 × ULN, urine glucose ≥1, ketones ≥1, urine hemoglobin ≥1, urine bilirubin ≥1, leukocyte esterase ≥1, epithelial cells ≥6/LPF, urinalysis-bacteria/HPF.
Outcome measures
| Measure |
PBO SAD
n=14 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=15 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=11 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
cholesterol (mg/dL) >1.3 x ULN
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Urine glucose ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Ketones ≥1
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Urine hemoglobin ≥1
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Urine bilirubin ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Leukocyte esterase ≥1
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Epithelial cells (/LPF) ≥6
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Reticulocytes/erythrocytes (%) >1.5 x ULN
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Lymphocytes (10^3/mm^3) <0.8 x LLN
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Neutrophils (10^3/mm^3) <0.8 x LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Neutrophils (10^3/mm^3) >1.2 x ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Eosinophils (10^3/mm^3) >1.2 x ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Bilirubin (mg/dL) >1.5 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
ALT (U/L) >3 x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Creatinine (mg/dL) >1.3 x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Urate (mg/dL) >1.2 x ULN
|
7 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
HDL cholesterol (mg/dL) <0.8 x LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
LDL cholesterol (mg/dL) >1.2 x ULN
|
11 Participants
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Triglycerides (mg/dL) >1.3 x ULN
|
6 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Potassium (mEq/L) >1.1 x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Bicarbonate (mEq/L) >1.1 x ULN
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Glucose (mg/dL) <0.6 x LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Glucose (mg/dL) >1.5 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Urinalysis-bacteria (/HPF) >20
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
CK (U/L) >2 x ULN
|
4 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -1 and Day 10Population: The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.
Change in 24-hour creatinine clearance at Day 10 from Day -1 (baseline) during the MAD was presented by treatment group.
Outcome measures
| Measure |
PBO SAD
n=9 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=1 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
n=5 Participants
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period)
|
-21.0 milliliters per minute (mL/min)
Standard Deviation 98.76
|
-32.0 milliliters per minute (mL/min)
Standard Deviation NA
One (1) participant was analyzed, so standard deviation did not exist.
|
-62.4 milliliters per minute (mL/min)
Standard Deviation 45.10
|
0.2 milliliters per minute (mL/min)
Standard Deviation 65.64
|
-52.5 milliliters per minute (mL/min)
Standard Deviation 56.22
|
-11.4 milliliters per minute (mL/min)
Standard Deviation 58.76
|
-64.7 milliliters per minute (mL/min)
Standard Deviation 36.22
|
40.2 milliliters per minute (mL/min)
Standard Deviation 45.26
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dosePopulation: The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=3 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=4 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period)
|
47.63 nanograms*hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 59
|
369.3 nanograms*hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 67
|
848.4 nanograms*hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 40
|
1582 nanograms*hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 42
|
3056 nanograms*hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 65
|
11790 nanograms*hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 25
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dosePopulation: The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). AUCinf(dn) = AUCinf / dose. Dose normalized AUC values of PF-06826647 was plotted against dose and included individual participant values and the geometric means for each dose. These plots were used to help understand the relationship between the plasma PK parameters and dose.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=3 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=4 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Secondary: Dose Normalized AUCinf (AUCinf[dn]) (SAD Period)
|
15.86 ng*hr/mL/mg
Geometric Coefficient of Variation 59
|
36.93 ng*hr/mL/mg
Geometric Coefficient of Variation 67
|
28.28 ng*hr/mL/mg
Geometric Coefficient of Variation 41
|
15.82 ng*hr/mL/mg
Geometric Coefficient of Variation 42
|
7.636 ng*hr/mL/mg
Geometric Coefficient of Variation 65
|
7.370 ng*hr/mL/mg
Geometric Coefficient of Variation 25
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
AUC24 was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
Outcome measures
| Measure |
PBO SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period)
|
43.10 ng*hr/mL
Geometric Coefficient of Variation 56
|
347.8 ng*hr/mL
Geometric Coefficient of Variation 62
|
543.2 ng*hr/mL
Geometric Coefficient of Variation 49
|
1158 ng*hr/mL
Geometric Coefficient of Variation 55
|
2519 ng*hr/mL
Geometric Coefficient of Variation 67
|
9318 ng*hr/mL
Geometric Coefficient of Variation 34
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dosePopulation: The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
AUClast was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
Outcome measures
| Measure |
PBO SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period)
|
40.25 ng*hr/mL
Geometric Coefficient of Variation 56
|
354.8 ng*hr/mL
Geometric Coefficient of Variation 67
|
638.5 ng*hr/mL
Geometric Coefficient of Variation 58
|
1375 ng*hr/mL
Geometric Coefficient of Variation 53
|
2767 ng*hr/mL
Geometric Coefficient of Variation 65
|
9921 ng*hr/mL
Geometric Coefficient of Variation 32
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dosePopulation: The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
AUClast(dn) = AUClast / dose. Dose normalized AUC values of PF-06826647 were plotted against dose and included individual participant values and the geometric means for each dose. These plots was used to help understand the relationship between the plasma PK parameters and dose.
Outcome measures
| Measure |
PBO SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Normalized AUClast (AUClast[dn]) (SAD Period)
|
13.40 ng*hr/mL/mg
Geometric Coefficient of Variation 56
|
35.48 ng*hr/mL/mg
Geometric Coefficient of Variation 67
|
21.28 ng*hr/mL/mg
Geometric Coefficient of Variation 58
|
13.75 ng*hr/mL/mg
Geometric Coefficient of Variation 53
|
6.919 ng*hr/mL/mg
Geometric Coefficient of Variation 65
|
6.200 ng*hr/mL/mg
Geometric Coefficient of Variation 32
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dosePopulation: The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Outcome measures
| Measure |
PBO SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) (SAD Period)
|
7.844 ng/mL
Geometric Coefficient of Variation 38
|
47.09 ng/mL
Geometric Coefficient of Variation 35
|
77.93 ng/mL
Geometric Coefficient of Variation 34
|
166.8 ng/mL
Geometric Coefficient of Variation 55
|
404.8 ng/mL
Geometric Coefficient of Variation 62
|
1218 ng/mL
Geometric Coefficient of Variation 25
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dosePopulation: The analysis population included healthy participants who received the study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.
Outcome measures
| Measure |
PBO SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Normalized Cmax (Cmax[dn]) (SAD Period)
|
2.617 ng/mL/mg
Geometric Coefficient of Variation 38
|
4.709 ng/mL/mg
Geometric Coefficient of Variation 35
|
2.597 ng/mL/mg
Geometric Coefficient of Variation 34
|
1.668 ng/mL/mg
Geometric Coefficient of Variation 55
|
1.012 ng/mL/mg
Geometric Coefficient of Variation 62
|
0.7618 ng/mL/mg
Geometric Coefficient of Variation 25
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dosePopulation: The analysis population included healthy participants who received the study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PBO SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=8 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) (SAD Period)
|
2.00 hours (hr)
Interval 1.0 to 2.0
|
2.00 hours (hr)
Interval 1.0 to 4.0
|
2.00 hours (hr)
Interval 1.0 to 4.0
|
2.00 hours (hr)
Interval 2.0 to 6.0
|
2.00 hours (hr)
Interval 0.5 to 4.0
|
2.00 hours (hr)
Interval 0.5 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dosePopulation: The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=3 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=4 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life ((t½) (SAD Period)
|
3.620 hours (hr)
Standard Deviation 1.2956
|
6.032 hours (hr)
Standard Deviation 1.9050
|
19.69 hours (hr)
Standard Deviation 9.5144
|
38.77 hours (hr)
Standard Deviation 35.966
|
16.25 hours (hr)
Standard Deviation 9.3430
|
22.21 hours (hr)
Standard Deviation 24.586
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dosePopulation: The analysis population included healthy participants who received the study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=3 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=4 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Residence Time (MRT) (SAD Period)
|
5.596 hours (hr)
Geometric Coefficient of Variation 26
|
7.761 hours (hr)
Geometric Coefficient of Variation 30
|
16.97 hours (hr)
Geometric Coefficient of Variation 43
|
21.23 hours (hr)
Geometric Coefficient of Variation 81
|
10.56 hours (hr)
Geometric Coefficient of Variation 36
|
9.417 hours (hr)
Geometric Coefficient of Variation 33
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dosePopulation: The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=3 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=4 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) (SAD Period)
|
312.1 liters (L)
Geometric Coefficient of Variation 34
|
226.1 liters (L)
Geometric Coefficient of Variation 41
|
902.9 liters (L)
Geometric Coefficient of Variation 81
|
2671 liters (L)
Geometric Coefficient of Variation 134
|
2732 liters (L)
Geometric Coefficient of Variation 128
|
2877 liters (L)
Geometric Coefficient of Variation 146
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dosePopulation: The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=3 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=4 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) (SAD Period)
|
62.98 liters per hour (L/hr)
Geometric Coefficient of Variation 59
|
27.08 liters per hour (L/hr)
Geometric Coefficient of Variation 67
|
35.36 liters per hour (L/hr)
Geometric Coefficient of Variation 41
|
63.21 liters per hour (L/hr)
Geometric Coefficient of Variation 42
|
130.8 liters per hour (L/hr)
Geometric Coefficient of Variation 65
|
135.4 liters per hour (L/hr)
Geometric Coefficient of Variation 26
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
AUCτ was summarized by dosing regimen and period. Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval was 24 hours for QD dosing and 12 hours for BID dosing. It was determined by linear/log trapezoidal method.
Outcome measures
| Measure |
PBO SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval τ (AUCτ) (MAD Period Day 1)
|
662.8 ng*hr/mL
Geometric Coefficient of Variation 25
|
1803 ng*hr/mL
Geometric Coefficient of Variation 23
|
1646 ng*hr/mL
Geometric Coefficient of Variation 70
|
4424 ng*hr/mL
Geometric Coefficient of Variation 67
|
6038 ng*hr/mL
Geometric Coefficient of Variation 29
|
17090 ng*hr/mL
Geometric Coefficient of Variation 20
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Area Under the Plasma Concentration-Time Profile over the Dosing interval τ (AUCτ). Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose.
Outcome measures
| Measure |
PBO SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Normalized AUCτ (AUCτ[dn]) (MAD Period Day 1)
|
22.10 ng*hr/mL/mg
Geometric Coefficient of Variation 25
|
18.03 ng*hr/mL/mg
Geometric Coefficient of Variation 23
|
8.229 ng*hr/mL/mg
Geometric Coefficient of Variation 70
|
11.07 ng*hr/mL/mg
Geometric Coefficient of Variation 67
|
15.10 ng*hr/mL/mg
Geometric Coefficient of Variation 29
|
14.23 ng*hr/mL/mg
Geometric Coefficient of Variation 20
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Outcome measures
| Measure |
PBO SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax (MAD Period Day 1)
|
83.53 ng/mL
Geometric Coefficient of Variation 24
|
267.2 ng/mL
Geometric Coefficient of Variation 20
|
289.8 ng/mL
Geometric Coefficient of Variation 67
|
585.9 ng/mL
Geometric Coefficient of Variation 33
|
695.5 ng/mL
Geometric Coefficient of Variation 19
|
2023 ng/mL
Geometric Coefficient of Variation 10
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.
Outcome measures
| Measure |
PBO SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax(dn) (MAD Period Day 1)
|
2.787 ng/mL/mg
Geometric Coefficient of Variation 24
|
2.672 ng/mL/mg
Geometric Coefficient of Variation 20
|
1.450 ng/mL/mg
Geometric Coefficient of Variation 67
|
1.468 ng/mL/mg
Geometric Coefficient of Variation 33
|
1.741 ng/mL/mg
Geometric Coefficient of Variation 19
|
1.686 ng/mL/mg
Geometric Coefficient of Variation 10
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PBO SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=7 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax (MAD Period Day 1)
|
3.00 hours (hr)
Interval 2.0 to 6.0
|
4.00 hours (hr)
Interval 1.0 to 4.0
|
4.00 hours (hr)
Interval 2.0 to 6.0
|
3.00 hours (hr)
Interval 2.0 to 6.0
|
4.00 hours (hr)
Interval 2.0 to 4.0
|
2.00 hours (hr)
Interval 2.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
AUCτ was summarized by dosing regimen and period. Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval was 24 hours for QD dosing and 12 hours for BID dosing. It was determined by linear/log trapezoidal method.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
AUCτ (MAD Period Day 10)
|
752.9 ng*hr/mL
Geometric Coefficient of Variation 32
|
1952 ng*hr/mL
Geometric Coefficient of Variation 33
|
2010 ng*hr/mL
Geometric Coefficient of Variation 49
|
5420 ng*hr/mL
Geometric Coefficient of Variation 57
|
7194 ng*hr/mL
Geometric Coefficient of Variation 20
|
14890 ng*hr/mL
Geometric Coefficient of Variation 31
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Area Under the Plasma Concentration-Time Profile over the Dosing interval τ (AUCτ). Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
AUCτ(dn) (MAD Period Day 10)
|
25.06 ng*hr/mL/mg
Geometric Coefficient of Variation 32
|
19.52 ng*hr/mL/mg
Geometric Coefficient of Variation 33
|
10.04 ng*hr/mL/mg
Geometric Coefficient of Variation 49
|
13.56 ng*hr/mL/mg
Geometric Coefficient of Variation 57
|
18.00 ng*hr/mL/mg
Geometric Coefficient of Variation 19
|
12.41 ng*hr/mL/mg
Geometric Coefficient of Variation 31
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax (MAD Period Day 10)
|
85.34 ng/mL
Geometric Coefficient of Variation 27
|
263.2 ng/mL
Geometric Coefficient of Variation 30
|
339.5 ng/mL
Geometric Coefficient of Variation 46
|
667.3 ng/mL
Geometric Coefficient of Variation 37
|
887.0 ng/mL
Geometric Coefficient of Variation 11
|
1855 ng/mL
Geometric Coefficient of Variation 21
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax(dn) (MAD Period Day 10)
|
2.844 ng/mL/mg
Geometric Coefficient of Variation 27
|
2.632 ng/mL/mg
Geometric Coefficient of Variation 30
|
1.701 ng/mL/mg
Geometric Coefficient of Variation 46
|
1.669 ng/mL/mg
Geometric Coefficient of Variation 37
|
2.220 ng/mL/mg
Geometric Coefficient of Variation 11
|
1.547 ng/mL/mg
Geometric Coefficient of Variation 21
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax (MAD Period Day 10)
|
4.00 hours (hr)
Interval 4.0 to 6.0
|
4.00 hours (hr)
Interval 2.0 to 4.0
|
4.00 hours (hr)
Interval 2.0 to 4.0
|
4.00 hours (hr)
Interval 2.0 to 6.0
|
4.00 hours (hr)
Interval 2.0 to 6.0
|
4.00 hours (hr)
Interval 2.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Cav = AUCτ,ss / τ, where ss means 'at steady state', and where the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Cav was summarized by dosing regimen and period.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Average Concentration at Steady State (Cav) (MAD Period Day 10)
|
31.36 ng/mL
Geometric Coefficient of Variation 32
|
81.28 ng/mL
Geometric Coefficient of Variation 34
|
167.6 ng/mL
Geometric Coefficient of Variation 49
|
226.0 ng/mL
Geometric Coefficient of Variation 57
|
299.7 ng/mL
Geometric Coefficient of Variation 20
|
619.9 ng/mL
Geometric Coefficient of Variation 31
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Cmin was observed directly from data. It was summarized by dosing regimen and period. Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Lowest Concentration Observed During the Dosing Interval τ (Cmin) (MAD Period Day 10)
|
6.273 ng/mL
Geometric Coefficient of Variation 83
|
10.40 ng/mL
Geometric Coefficient of Variation 75
|
55.01 ng/mL
Geometric Coefficient of Variation 65
|
24.77 ng/mL
Geometric Coefficient of Variation 148
|
29.50 ng/mL
Geometric Coefficient of Variation 60
|
62.26 ng/mL
Geometric Coefficient of Variation 112
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=3 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=4 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=4 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life ((t½) (MAD Period Day 10)
|
8.802 hours (hr)
Standard Deviation 5.8142
|
12.72 hours (hr)
Standard Deviation 12.644
|
26.93 hours (hr)
Standard Deviation 8.1132
|
7.500 hours (hr)
Standard Deviation 2.5803
|
7.433 hours (hr)
Standard Deviation 4.7975
|
34.33 hours (hr)
Standard Deviation 21.926
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=3 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=4 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=4 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
MRT (MAD Period Day 10)
|
10.56 hours (hr)
Geometric Coefficient of Variation 44
|
9.872 hours (hr)
Geometric Coefficient of Variation 33
|
17.14 hours (hr)
Geometric Coefficient of Variation 26
|
9.622 hours (hr)
Geometric Coefficient of Variation 26
|
7.996 hours (hr)
Geometric Coefficient of Variation 19
|
9.165 hours (hr)
Geometric Coefficient of Variation 24
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It was summarized by dosing regimen and period.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Peak Trough Ratio (PTR) (MAD Period Day 10)
|
13.61 ratio
Geometric Coefficient of Variation 69
|
25.31 ratio
Geometric Coefficient of Variation 55
|
6.951 ratio
Geometric Coefficient of Variation 23
|
26.92 ratio
Geometric Coefficient of Variation 112
|
30.09 ratio
Geometric Coefficient of Variation 61
|
29.76 ratio
Geometric Coefficient of Variation 97
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Rac = AUCτ,ss / AUCτ,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCτ(Day 10) / AUCτ(Day 1). Rac was summarized by dosing regimen and period.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10)
|
1.085 ratio
Geometric Coefficient of Variation 8
|
1.082 ratio
Geometric Coefficient of Variation 21
|
1.328 ratio
Geometric Coefficient of Variation 52
|
1.225 ratio
Geometric Coefficient of Variation 39
|
1.191 ratio
Geometric Coefficient of Variation 24
|
0.8711 ratio
Geometric Coefficient of Variation 30
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Rac,Cmax = Cmax,ss / Cmax,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac,Cmax = Cmax(Day10) / Cmax(Day 1). Rac,Cmax was summarized by dosing regimen and period.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10)
|
0.9295 ratio
Geometric Coefficient of Variation 22
|
0.9852 ratio
Geometric Coefficient of Variation 24
|
1.282 ratio
Geometric Coefficient of Variation 57
|
1.139 ratio
Geometric Coefficient of Variation 35
|
1.275 ratio
Geometric Coefficient of Variation 14
|
0.9176 ratio
Geometric Coefficient of Variation 25
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=3 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=4 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=4 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Vz/F (MAD Period Day 10)
|
433.5 liters (L)
Geometric Coefficient of Variation 52
|
643.6 liters (L)
Geometric Coefficient of Variation 98
|
3224 liters (L)
Geometric Coefficient of Variation 90
|
758.9 liters (L)
Geometric Coefficient of Variation 93
|
519.2 liters (L)
Geometric Coefficient of Variation 67
|
2944 liters (L)
Geometric Coefficient of Variation 166
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
CL/F (MAD Period Day 10)
|
39.86 liters per hour (L/hr)
Geometric Coefficient of Variation 32
|
51.27 liters per hour (L/hr)
Geometric Coefficient of Variation 34
|
99.47 liters per hour (L/hr)
Geometric Coefficient of Variation 49
|
73.78 liters per hour (L/hr)
Geometric Coefficient of Variation 57
|
55.62 liters per hour (L/hr)
Geometric Coefficient of Variation 20
|
80.63 liters per hour (L/hr)
Geometric Coefficient of Variation 31
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Aeτ = Sum of \[urine concentration \* sample volume\] for each collection interval. Aer was summarized by dosing regimen and period.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10)
|
0.2204 mg
Geometric Coefficient of Variation 35
|
1.072 mg
Geometric Coefficient of Variation 65
|
2.560 mg
Geometric Coefficient of Variation 66
|
3.134 mg
Geometric Coefficient of Variation 75
|
2.931 mg
Geometric Coefficient of Variation 624
|
14.73 mg
Geometric Coefficient of Variation 92
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Aeτ% = Aeτ / Dose \* 100. Aeτ%was summarized by dosing regimen and period.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10)
|
0.7344 Percentage of Dose
Geometric Coefficient of Variation 35
|
1.072 Percentage of Dose
Geometric Coefficient of Variation 65
|
1.280 Percentage of Dose
Geometric Coefficient of Variation 66
|
0.7827 Percentage of Dose
Geometric Coefficient of Variation 75
|
0.7333 Percentage of Dose
Geometric Coefficient of Variation 624
|
1.228 Percentage of Dose
Geometric Coefficient of Variation 92
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dosePopulation: The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aeτ) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCτ), where dosing interval is 24 hours for QD dosing and 12 hours for BID dosing.
Outcome measures
| Measure |
PBO SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
n=6 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
n=5 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Renal Clearance (Clr) (MAD Period Day 10)
|
0.2928 L/hr
Geometric Coefficient of Variation 70
|
0.5500 L/hr
Geometric Coefficient of Variation 42
|
1.274 L/hr
Geometric Coefficient of Variation 39
|
0.5777 L/hr
Geometric Coefficient of Variation 34
|
0.4076 L/hr
Geometric Coefficient of Variation 500
|
0.9909 L/hr
Geometric Coefficient of Variation 58
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dosePopulation: The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
AUCτ was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
Outcome measures
| Measure |
PBO SAD
n=10 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
AUCτ (Psoriasis Cohorts)
|
2401 ng*hr/mL
Geometric Coefficient of Variation 53
|
7664 ng*hr/mL
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dosePopulation: The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose.
Outcome measures
| Measure |
PBO SAD
n=10 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
AUCτ(dn) (Psoriasis Cohorts)
|
24.01 ng*hr/mL/mg
Geometric Coefficient of Variation 53
|
19.17 ng*hr/mL/mg
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dosePopulation: The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Outcome measures
| Measure |
PBO SAD
n=10 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax (Psoriasis Cohorts)
|
296.6 ng/mL
Geometric Coefficient of Variation 38
|
869.8 ng/mL
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dosePopulation: The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Outcome measures
| Measure |
PBO SAD
n=10 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax(dn) (Psoriasis Cohorts)
|
2.966 ng/mL/mg
Geometric Coefficient of Variation 38
|
2.176 ng/mL/mg
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dosePopulation: The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PBO SAD
n=10 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax (Psoriasis Cohorts)
|
4.00 hours (hr)
Interval 1.0 to 6.0
|
4.00 hours (hr)
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dosePopulation: The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Cav = AUCτ,ss / τ, where ss means 'at steady state'. Cav was summarized by dosing regimen and period.
Outcome measures
| Measure |
PBO SAD
n=10 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cav (Psoriasis Cohorts)
|
100.2 ng/mL
Geometric Coefficient of Variation 53
|
319.3 ng/mL
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dosePopulation: The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Cmin was observed directly from data. It was summarized by dosing regimen and period.
Outcome measures
| Measure |
PBO SAD
n=10 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cmin (Psoriasis Cohorts)
|
21.92 ng/mL
Geometric Coefficient of Variation 103
|
38.12 ng/mL
Geometric Coefficient of Variation 176
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dosePopulation: The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
Outcome measures
| Measure |
PBO SAD
n=10 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=11 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life ((t½) (Psoriasis Cohorts)
|
7.796 hours (hr)
Standard Deviation 5.7087
|
6.809 hours (hr)
Standard Deviation 5.4050
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dosePopulation: The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
Outcome measures
| Measure |
PBO SAD
n=10 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=11 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
MRT (Psoriasis Cohorts)
|
11.27 hours (hr)
Geometric Coefficient of Variation 41
|
9.444 hours (hr)
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dosePopulation: The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
PTR = Cmax,ss / Cmin,ss, it was summarized by dosing regimen and period.
Outcome measures
| Measure |
PBO SAD
n=10 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
PTR (Psoriasis Cohorts)
|
13.52 ratio
Geometric Coefficient of Variation 76
|
22.81 ratio
Geometric Coefficient of Variation 171
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dosePopulation: The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
PBO SAD
n=10 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=11 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Vz/F (Psoriasis Cohorts)
|
408.1 liters (L)
Geometric Coefficient of Variation 30
|
461.2 liters (L)
Geometric Coefficient of Variation 54
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dosePopulation: The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
PBO SAD
n=10 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
CL/F (Psoriasis Cohorts)
|
41.61 L/hr
Geometric Coefficient of Variation 53
|
52.21 L/hr
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: The analysis population included psoriasis participants who received the 28-day study treatment and who had the efficacy parameters at Baseline and on Day 28 in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
Outcome measures
| Measure |
PBO SAD
n=12 Participants
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in \[PBO SAD (3mg, 10mg)\] cohorts + participants in \[PBO SAD -\> PBO QD\] cohorts.
|
PF-06826647 3 mg SAD
n=13 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
|
PF-06826647 10 mg SAD
n=11 Participants
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
|
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
|
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
|
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
|
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
|
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 28
|
-11.13 score on a scale
Standard Error 2.405
|
-24.18 score on a scale
Standard Error 2.281
|
-14.62 score on a scale
Standard Error 2.505
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo SAD
Placebo QD MAD (JP Placebo Included)
Placebo BID
PF-06826647 3 mg SAD
PF-06826647 10 mg SAD
PF-06826647 30 mg SAD
PF-06826647 30 mg QD MAD
PF-06826647 100 mg SAD
PF-06826647 100 mg QD MAD
PF-06826647 400 mg SAD
PF-06826647 400 mg QD MAD
PF-06826647 1600 mg SAD
PF-06826647 1200 mg QD MAD
PF-06826647 200 mg BID
PF-06826647 400 mg QD MAD JP
Placebo QD PSO
PF-06826647 400 mg QD PSO
PF-06826647 100 mg QD PSO
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo SAD
n=13 participants at risk
During the SAD period (Period 1), the healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg cohort SD cohort in fasted state. SAD period duration was 8 days. (Those placebo participants matching 30, 100, 400, or 1600 SD cohort later continued into MAD period and received the placebo matching 30, 100, 400, or 1200 mg QD cohort, respectively.)
|
Placebo QD MAD (JP Placebo Included)
n=9 participants at risk
This arm includes both non-Japanese and Japanese participants. In MAD period (Period 2), the non-Japanese participants (they had completed the SAD period) received placebo matching PF-06826647 30, 100, 400, or 1200 mg QD cohort while the Japanese participants (they did not take part in SAD period) received placebo matching PF-06826647 400 mg QD Japanese cohort, both for 10 days with standard meal. MAD period duration was 28 days.
|
Placebo BID
n=2 participants at risk
Edit During the MAD period (Period 2), the healthy participants received placebo matching PF-06826647 200 mg BID cohort for 10 days with standard meal. MAD period duration was 28 days.
|
PF-06826647 3 mg SAD
n=6 participants at risk
During the SAD period (Period 1), the healthy participants received PF-06826647 3 mg SD in fasted state. SAD period duration was 8 days.
|
PF-06826647 10 mg SAD
n=6 participants at risk
During the SAD period (Period 1), the healthy participants received PF-06826647 10 mg SD in fasted state. SAD period duration was 8 days.
|
PF-06826647 30 mg SAD
n=8 participants at risk
During the SAD period (Period 1), the healthy participants received PF-06826647 30 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 30 mg QD in MAD period.)
|
PF-06826647 30 mg QD MAD
n=6 participants at risk
During the MAD period (Period 2), the healthy participants who had taken PF-06826647 30 mg SD received PF-06826647 30 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
PF-06826647 100 mg SAD
n=7 participants at risk
During the SAD period (Period 1), the healthy participants received PF-06826647 100 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 100 mg QD in MAD period.)
|
PF-06826647 100 mg QD MAD
n=6 participants at risk
During the MAD period (Period 2), the healthy participants who had taken PF-06826647 100 mg SD received PF-06826647 100 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
PF-06826647 400 mg SAD
n=8 participants at risk
During the SAD period (Period 1), the healthy participants received PF-06826647 400 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 400 mg QD in MAD period.)
|
PF-06826647 400 mg QD MAD
n=6 participants at risk
During the MAD period (Period 2), the healthy participants who had taken PF-06826647 400 mg SD received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
PF-06826647 1600 mg SAD
n=6 participants at risk
During the SAD period (Period 1), the healthy participants received PF-06826647 1600 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 1200 mg QD in MAD period.)
|
PF-06826647 1200 mg QD MAD
n=5 participants at risk
During the MAD period (Period 2), the healthy participants who had taken PF-06826647 1600 mg SD received PF-06826647 1200 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
PF-06826647 200 mg BID
n=7 participants at risk
During the MAD period (Period 2), the healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
|
PF-06826647 400 mg QD MAD JP
n=5 participants at risk
During the MAD period (Period 2), the Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
|
Placebo QD PSO
n=14 participants at risk
In the psoriasis (PSO) cohorts, the psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD PSO cohort for 28 days with standard meal. Psoriasis cohort duration was 84 days.
|
PF-06826647 400 mg QD PSO
n=15 participants at risk
In this psoriasis cohort, the psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
|
PF-06826647 100 mg QD PSO
n=11 participants at risk
In this psoriasis cohort, the psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
7.1%
1/14 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
9.1%
1/11 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
13.3%
2/15 • Number of events 2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
14.3%
2/14 • Number of events 2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
7.1%
1/14 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
7.1%
1/14 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
General disorders
Face oedema
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
General disorders
Oedema
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
General disorders
Peripheral swelling
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
7.1%
1/14 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
General disorders
Secretion discharge
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
7.1%
1/14 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
9.1%
1/11 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
7.1%
1/14 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
9.1%
1/11 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
20.0%
1/5 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
9.1%
1/11 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Investigations
Blood creatine phosphokinase
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
9.1%
1/11 • Number of events 2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
11.1%
1/9 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
20.0%
1/5 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
42.9%
3/7 • Number of events 4 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
14.3%
2/14 • Number of events 2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
20.0%
3/15 • Number of events 5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
18.2%
2/11 • Number of events 2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Investigations
Body temperature
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
7.1%
1/14 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
7.1%
1/14 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
9.1%
1/11 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
20.0%
1/5 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
7.1%
1/14 • Number of events 2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
13.3%
2/15 • Number of events 3 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
9.1%
1/11 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
13.3%
2/15 • Number of events 2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
11.1%
1/9 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
13.3%
2/15 • Number of events 2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
9.1%
1/11 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 4 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
6.7%
1/15 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
7.1%
1/14 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/13 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/9 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/2 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/8 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/6 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/7 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/5 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/14 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/15 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
0.00%
0/11 • Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER