Trial Outcomes & Findings for A Study to Learn About Study Medicine Called PF-07261271 in Healthy People (NCT NCT05536440)
NCT ID: NCT05536440
Last Updated: 2025-03-24
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the last follow-up date, were considered as TEAEs. AEs included all SAEs and Non-SAEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
From start of study intervention (Day 1) up to end of study, approximately up to 15 months
Results posted on
2025-03-24
Participant Flow
A total of 35 participants (27 participants assigned to single ascending dose \[SAD\] cohorts and 8 participants assigned in the multiple doses \[MD\] cohorts) were enrolled in the study.
In this study, dose have been reported from dose levels 1 to 4, wherein dose level 1 is the lowest dose and dose level 4 is the highest dose received by the study participants.
Participant milestones
| Measure |
SAD: Placebo
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single intravenous (IV) dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
Healthy participants who were randomized to receive PF-07261271 Dose Level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 Dose Level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 Dose Level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 Dose Level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 Dose Level 4 as single IV dose on Day 1.
|
MD: Placebo
Healthy participants who were randomized to receive placebo matched to PF-07261271 as repeated subcutaneous (SC) doses on Day 1 and Day 29.
|
MD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 Dose Level 3 repeated SC doses on Day 1 and Day 29.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
2
|
2
|
4
|
6
|
1
|
4
|
2
|
6
|
|
Overall Study
COMPLETED
|
8
|
2
|
2
|
4
|
6
|
1
|
4
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
SAD: Placebo
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single intravenous (IV) dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
Healthy participants who were randomized to receive PF-07261271 Dose Level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 Dose Level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 Dose Level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 Dose Level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 Dose Level 4 as single IV dose on Day 1.
|
MD: Placebo
Healthy participants who were randomized to receive placebo matched to PF-07261271 as repeated subcutaneous (SC) doses on Day 1 and Day 29.
|
MD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 Dose Level 3 repeated SC doses on Day 1 and Day 29.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Learn About Study Medicine Called PF-07261271 in Healthy People
Baseline characteristics by cohort
| Measure |
SAD: Placebo
n=8 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 Dose Level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 Dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 Dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 Dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
n=1 Participants
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
n=4 Participants
Healthy Japanese participants who were randomized to receive PF-07261271 Dose level 4 as single IV dose on Day 1.
|
MD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as repeated subcutaneous (SC) doses on Day 1 and Day 29.
|
MD: PF-07261271 Dose Level 3
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 Dose level 3 repeated escalating SC doses on Day 1 and Day 29.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Less than (<) 18 Years
|
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
|
|
Age, Customized
18-25 Years
|
2 Participants
n=5 Participants
|
1 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
|
3 Participants
n=42 Participants
|
|
Age, Customized
26-35 Years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Age, Customized
36-45 Years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Age, Customized
Greater than (>) 45 Years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
29 Participants
n=42 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
23 Participants
n=42 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
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 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
|
PRIMARY outcome
Timeframe: From start of study intervention (Day 1) up to end of study, approximately up to 15 monthsPopulation: Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the last follow-up date, were considered as TEAEs. AEs included all SAEs and Non-SAEs.
Outcome measures
| Measure |
SAD: Placebo
n=8 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
n=1 Participants
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
n=4 Participants
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs): SAD Cohort
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From start of study intervention (Day 1) up to end of study, approximately of 15.5 monthsPopulation: Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the last follow-up date, were considered as TEAEs. AEs included all SAEs and Non-SAEs.
Outcome measures
| Measure |
SAD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs): MD Cohort
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study intervention (Day 1) up to end of study, approximately up to 15 monthsPopulation: Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medically significant event.
Outcome measures
| Measure |
SAD: Placebo
n=8 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
n=1 Participants
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
n=4 Participants
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs): SAD Cohort
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study intervention (Day 1) up to end of study, approximately of 15.5 monthsPopulation: Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medically significant event.
Outcome measures
| Measure |
SAD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs): MD Cohort
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study intervention (Day 1) up to end of study, approximately up to 15 monthsPopulation: Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
Criteria for abnormal values of vital signs: systolic blood pressure (millimeters of mercury \[mmHg\]) value less than (\<) 90 mmHg, change greater than or equal to (\>=) 30 mmHg increase, change \>= 30 mmHg decrease; diastolic blood pressure (mmHg), value \<50 mmHg, change \>=20 mmHg increase, change \>=20 mmHg decrease; pulse rate (beats per minute \[bpm\]) value \<40bpm, value greater than (\>) 120bpm. Clinical significance was determined based on investigator's discretion.
Outcome measures
| Measure |
SAD: Placebo
n=8 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
n=1 Participants
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
n=4 Participants
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: SAD Cohort
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study intervention (Day 1) up to end of study, approximately of 15.5 monthsPopulation: Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
Criteria for abnormal values of vital signs: systolic blood pressure (mmHg) value \< 90 mmHg, change \>= 30 mmHg increase, change \>= 30 mmHg decrease; diastolic blood pressure (mmHg), value \<50 mmHg, change \>=20 mmHg increase, change \>=20 mmHg decrease; pulse rate (bpm) value \< 40bpm, value \> 120bpm. Clinical significance was determined based on investigator's discretion.
Outcome measures
| Measure |
SAD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: MD Cohort
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study intervention (Day 1) up to end of study, approximately up to 15 monthsPopulation: Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
Criteria:Hematology(Activated partial thromboplastin time\>1.1\*upper limit of normal(ULN); Basophils \&eosinophils\>1.2\*ULN; erythrocytes,hematocrit,hemoglobin,lymphocytes,neutrophils \<0.8\*lower limit of normal(LLN); leukocytes \<0.6\*LLN, \>1.5\*ULN; monocytes \>1.2\*ULN; platelets \<0.5\*LLN; prothrombin international randomized ratio \&prothrombin Time \>1.1\*ULN), clinical chemistry (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase \>3.0\*ULN; albumin, protein \<0.8\*LLN, \>1.2\*ULN; bicarbonate, calcium, chloride, potassium \<0.9\*LLN,\>1.1\*ULN; bilirubin \>1.5\*ULN; creatinine \>1.3\*ULN; glucose, Glucose-FASTING \<0.6\*LLN,\>1.5\*ULN; Sodium \<0.95\*LLN,\>1.05\*ULN; Urate: \>1.2\*ULN;Urea Nitrogen: \>1.3\*ULN),urinalysis(Bacteria \> 20;epithelial cells \>=6;granular, hyaline, RBC\&WBC casts \>1;ketones,leukocyte esterase, nitrite, urine glucose, urine hemoglobin, urine protein\>=1,urine erythrocytes,leukocytes \>=20;pH(scalar)\<4.5,\>8.Clinical significance determined on investigator's discretion.
Outcome measures
| Measure |
SAD: Placebo
n=8 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
n=1 Participants
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
n=4 Participants
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: SAD Cohort
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study intervention (Day 1) up to end of study, approximately of 15.5 monthsPopulation: Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
Criteria:Hematology(Activated partial thromboplastin time\>1.1\*upper limit of normal(ULN); Basophils \&eosinophils\>1.2\*ULN; erythrocytes,hematocrit,hemoglobin,lymphocytes,neutrophils \<0.8\*lower limit of normal(LLN); leukocytes \<0.6\*LLN, \>1.5\*ULN; monocytes \>1.2\*ULN; platelets \<0.5\*LLN; prothrombin international randomized ratio \&prothrombin Time \>1.1\*ULN), clinical chemistry (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase \>3.0\*ULN; albumin, protein \<0.8\*LLN, \>1.2\*ULN; bicarbonate, calcium, chloride, potassium \<0.9\*LLN,\>1.1\*ULN; bilirubin \>1.5\*ULN; creatinine \>1.3\*ULN; glucose, Glucose-FASTING \<0.6\*LLN,\>1.5\*ULN; Sodium \<0.95\*LLN,\>1.05\*ULN; Urate: \>1.2\*ULN;Urea Nitrogen: \>1.3\*ULN),urinalysis(Bacteria \> 20;epithelial cells \>=6;granular, hyaline, RBC\&WBC casts \>1;ketones,leukocyte esterase, nitrite, urine glucose, urine hemoglobin, urine protein\>=1,urine erythrocytes,leukocytes \>=20;pH(scalar)\<4.5,\>8.Clinical significance determined on investigator's discretion.
Outcome measures
| Measure |
SAD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: MD Cohort
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study intervention (Day 1) up to end of study, approximately up to 15 monthsPopulation: Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
Criteria for abnormal values of ECG parameters: pulse rate (PR) interval greater than or equal to (\>=)300 milliseconds (msec); PR interval change \>=25 percent (%) or \>=50 %, QRS interval \>=140 msec and QRS interval change: \>=50%. QT interval using Fridericia's correction (QTcF) range from 450 msec to less than (\<)480 msec, less than (\<) 480 msec to maximum less than or equal to (\<=)500 msec, \>500 msec, \<=30 to \<60 msec and \>=60 msec. Only rows which included at least 1 participant with abnormality are reported in this outcome measure. Clinical significance was determined based on investigator's discretion.
Outcome measures
| Measure |
SAD: Placebo
n=8 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
n=1 Participants
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
n=4 Participants
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Abnormalities: SAD Cohort
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study intervention (Day 1) up to end of study, approximately of 15.5 monthsPopulation: Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
Criteria for abnormal values of ECG parameters: pulse rate (PR) interval greater than or equal to (\>=)300 milliseconds (msec); PR interval change \>=25 percent (%) or \>=50 %, QRS interval \>=140 msec and QRS interval change: \>=50%. QT interval using Fridericia's correction (QTcF) range from 450 msec to less than (\<)480 msec, less than (\<) 480 msec to maximum less than or equal to (\<=)500 msec, \>500 msec, \<=30 to \<60 msec and \>=60 msec. Only rows which included at least 1 participant with abnormality are reported in this outcome measure. Clinical significance was determined based on investigator's discretion.
Outcome measures
| Measure |
SAD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in ECG Abnormalities: MD Cohort
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dosePopulation: Pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated.
AUClast was determined using Linear Log trapezoidal method.
Outcome measures
| Measure |
SAD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Time Point (AUClast) of PF-07261271: SAD Cohort
|
NA Nanograms*hour per milliliter
Geometric Coefficient of Variation NA
Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 3740000 Nanograms\*hour per milliliter (ng\*hr/mL) and 4200000 ng\*hr/mL.
|
NA Nanograms*hour per milliliter
Geometric Coefficient of Variation NA
Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 16300000 ng\*hr/mL and 20000000 ng\*hr/mL.
|
65600000 Nanograms*hour per milliliter
Geometric Coefficient of Variation 35
|
324100000 Nanograms*hour per milliliter
Geometric Coefficient of Variation 18
|
345000000 Nanograms*hour per milliliter
Geometric Coefficient of Variation 28
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dosePopulation: PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
AUCinf was determined as AUClast + (Clast\*/kel), where Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Outcome measures
| Measure |
SAD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=3 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07261271: SAD Cohort
|
NA Nanograms*hour per milliliter
Geometric Coefficient of Variation NA
Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 3740000 ng\*hr/mL and 4530000 ng\*hr/mL.
|
NA Nanograms*hour per milliliter
Geometric Coefficient of Variation NA
Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 16600000 ng\*hr/mL and 21300000 ng\*hr/mL.
|
61010000 Nanograms*hour per milliliter
Geometric Coefficient of Variation 36
|
332600000 Nanograms*hour per milliliter
Geometric Coefficient of Variation 18
|
368100000 Nanograms*hour per milliliter
Geometric Coefficient of Variation 28
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dosePopulation: PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated.
Cmax was defined as maximum serum concentration.
Outcome measures
| Measure |
SAD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of PF-07261271: SAD Cohort
|
NA Nanograms per milliliter
Geometric Coefficient of Variation NA
Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 10400 ng/mL and 10500 ng/mL.
|
NA Nanograms per milliliter
Geometric Coefficient of Variation NA
Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 46900 ng/mL and 50000 ng/mL.
|
143300 Nanograms per milliliter
Geometric Coefficient of Variation 21
|
372800 Nanograms per milliliter
Geometric Coefficient of Variation 17
|
313900 Nanograms per milliliter
Geometric Coefficient of Variation 31
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dosePopulation: PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated.
Tmax was defined as time for Cmax.
Outcome measures
| Measure |
SAD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of PF-07261271: SAD Cohort
|
NA Hours
Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 2.00 hours and 2.00 hours.
|
NA Hours
Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 1.08 hours and 13.2 hours.
|
2.12 Hours
Interval 1.0 to 4.0
|
3.13 Hours
Interval 0.967 to 5.53
|
5.26 Hours
Interval 2.17 to 48.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dosePopulation: PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
t1/2 was determined using Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear -concentration time- curve.
Outcome measures
| Measure |
SAD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=3 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of PF-07261271: SAD Cohort
|
NA Hours
Standard Deviation NA
Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 158 hours and 328 hours.
|
NA Hours
Standard Deviation NA
Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 297 hours and 299 hours.
|
330.7 Hours
Standard Deviation 193.29
|
1533 Hours
Standard Deviation 324.39
|
1529 Hours
Standard Deviation 1018.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29Population: PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.
AUCtau was defined as area under the concentration time profile from time zero to time tau (τ), the dosing interval, where tau=672 hours for every 4-week dosing. AUCtau was determined by Linear Log trapezoidal method.
Outcome measures
| Measure |
SAD: Placebo
n=6 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Profile From Time Zero to Time Tau (τ), the Dosing Interval (AUCtau) of PF-07261271: MD Cohort
Day 1
|
17600000 Nanograms*hour per milliliter
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration Time Profile From Time Zero to Time Tau (τ), the Dosing Interval (AUCtau) of PF-07261271: MD Cohort
Day 29
|
27900000 Nanograms*hour per milliliter
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29Population: PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.
Cmax was defined as maximum serum concentration.
Outcome measures
| Measure |
SAD: Placebo
n=6 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Cmax of PF-07261271: MD Cohort
Day 1
|
34120 Nanograms*hour per milliliter
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of PF-07261271: MD Cohort
Day 29
|
49600 Nanograms*hour per milliliter
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29Population: PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.
Tmax was defined as time for Cmax.
Outcome measures
| Measure |
SAD: Placebo
n=6 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Tmax of PF-07261271: MD Cohort
Day 1
|
253 Hours
Interval 48.0 to 338.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of PF-07261271: MD Cohort
Day 29
|
170 Hours
Interval 48.0 to 172.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29Population: PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated.
t1/2 was determined using Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear -concentration time- curve.
Outcome measures
| Measure |
SAD: Placebo
n=6 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of PF-07261271: MD Cohort
|
1150 Hours
Standard Deviation 856.40
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 15 monthsPopulation: Immunogenicity data analysis was performed on the safety analysis set.
ADA positive was defined as ADA titer \>= 100; ADA negative defined as ADA titer \< 100. Baseline was defined as the last pre-dose measurement
Outcome measures
| Measure |
SAD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADA) Against PF-07261271: SAD Cohort
|
2 Participants
|
2 Participants
|
4 Participants
Interval 19690.28 to
|
6 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 15.5 monthsPopulation: Immunogenicity data analysis was performed on the safety analysis set.
ADA positive defined as ADA titer \>= 100; ADA negative defined as ADA titer \< 100. Baseline was defined as the last pre-dose measurement.
Outcome measures
| Measure |
SAD: Placebo
n=6 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With ADA Against PF-07261271: MD Cohort
|
6 Participants
Interval 32249.01 to
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 15 monthsPopulation: Immunogenicity data analysis was performed on the safety analysis set.
NAb was determined by electrochemiluminescent (ECL) competitive ligand binding assay using the Meso Scale Discovery (MSD) platform.
Outcome measures
| Measure |
SAD: Placebo
n=2 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=6 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=4 Participants
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Neutralizing Antibodies (NAb) Against PF-07261271: SAD Cohort
|
2 Participants
|
2 Participants
|
4 Participants
Interval 19690.28 to
|
5 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 15.5 monthsPopulation: Immunogenicity data analysis was performed on the safety analysis set.
NAb was determined by electrochemiluminescent (ECL) competitive ligand binding assay using the Meso Scale Discovery (MSD) platform.
Outcome measures
| Measure |
SAD: Placebo
n=6 Participants
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With NAb Against PF-07261271: MD Cohort
|
5 Participants
Interval 32249.01 to
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SAD: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SAD: PF-07261271 Dose Level 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD: PF-07261271 Dose Level 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD: PF-07261271 Dose Level 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD: PF-07261271 Dose Level 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD: Placebo (Japanese Participants)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MD: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MD: PF-07261271 Dose Level 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAD: Placebo
n=8 participants at risk
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 1
n=2 participants at risk
Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 2
n=2 participants at risk
Healthy participants who were randomized to receive PF-07261271 Dose level 2 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 3
n=4 participants at risk
Healthy participants who were randomized to receive PF-07261271 Dose level 3 as single IV dose on Day 1.
|
SAD: PF-07261271 Dose Level 4
n=6 participants at risk
Healthy participants who were randomized to receive PF-07261271 Dose level 4 as single IV dose on Day 1.
|
SAD: Placebo (Japanese Participants)
n=1 participants at risk
Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single dose on Day 1.
|
SAD: PF-07261271 Dose Level 4 (Japanese Participants)
n=4 participants at risk
Healthy Japanese participants who were randomized to receive PF-07261271 Dose level 4 as single IV dose on Day 1.
|
MD: Placebo
n=2 participants at risk
Healthy participants who were randomized to receive placebo matched to PF-07261271 as repeated SC dose on Day 1 and Day 29.
|
MD: PF-07261271 Dose Level 3
n=6 participants at risk
Healthy participants who were randomized to receive PF-07261271 300 mg repeated escalating SC doses on Day 1 and Day 29.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
50.0%
1/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
16.7%
1/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
16.7%
1/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
16.7%
1/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
16.7%
1/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
General disorders
Asthenia
|
12.5%
1/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
General disorders
Chills
|
12.5%
1/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
General disorders
Injection site pain
|
12.5%
1/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
General disorders
Injection site reaction
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
50.0%
1/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
66.7%
4/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
16.7%
1/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
16.7%
1/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
50.0%
1/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
25.0%
1/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
25.0%
1/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
50.0%
1/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
50.0%
1/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
50.0%
1/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Investigations
Hepatic enzyme increased
|
25.0%
2/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
25.0%
1/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
50.0%
1/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
50.0%
1/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
25.0%
1/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Vascular disorders
Haematoma
|
12.5%
1/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
|
Vascular disorders
Hot flush
|
0.00%
0/8 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
25.0%
1/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/1 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/4 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/2 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
0.00%
0/6 • SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
|
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