Trial Outcomes & Findings for AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism (NCT NCT05239221)
NCT ID: NCT05239221
Last Updated: 2025-09-08
Results Overview
Number of Treatment Emergent Adverse Events (TEAEs), as assessed by medDRA (v25).
COMPLETED
PHASE1/PHASE2
132 participants
Up to 2 weeks in Part A and Part B, and up to 3 months in Part C
2025-09-08
Participant Flow
A total of 132 subjects were enrolled in the study. Of those, 52 subjects were enrolled in Part A (Phase 1), 52 subjects were enrolled in Part B (Phase 1), and 28 subjects were enrolled in Part C (Phase 2a).
Participant milestones
| Measure |
Part A (Cohort A1, 5 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
6
|
6
|
6
|
6
|
6
|
13
|
8
|
8
|
10
|
8
|
8
|
10
|
12
|
16
|
|
Overall Study
COMPLETED
|
3
|
6
|
6
|
6
|
6
|
6
|
5
|
13
|
8
|
8
|
8
|
7
|
8
|
10
|
12
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part A (Cohort A1, 5 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism
Baseline characteristics by cohort
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=3 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
n=13 Participants
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
n=8 Participants
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
n=8 Participants
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
n=10 Participants
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
n=8 Participants
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
n=8 Participants
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
n=10 Participants
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
n=12 Participants
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
n=16 Participants
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.3 years
n=5 Participants
|
38.8 years
n=7 Participants
|
23.7 years
n=5 Participants
|
30.0 years
n=4 Participants
|
26.3 years
n=21 Participants
|
21.0 years
n=10 Participants
|
35.3 years
n=115 Participants
|
29.2 years
n=24 Participants
|
38.3 years
n=42 Participants
|
42.9 years
n=42 Participants
|
39.7 years
n=42 Participants
|
30.1 years
n=42 Participants
|
33.3 years
n=36 Participants
|
32.0 years
n=36 Participants
|
62.7 years
n=24 Participants
|
54.0 years
n=135 Participants
|
37.9 years
n=136 Participants
|
|
Sex: Female, Male
Female
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
9 Participants
n=24 Participants
|
12 Participants
n=135 Participants
|
25 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
13 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
107 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
9 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
15 Participants
n=135 Participants
|
122 Participants
n=136 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
2 Participants
n=136 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
3 Participants
n=136 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
16 Participants
n=135 Participants
|
112 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
12 Participants
n=136 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
|
Region of Enrollment
Hungary
|
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=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
9 participants
n=24 Participants
|
6 participants
n=135 Participants
|
15 participants
n=136 Participants
|
|
Region of Enrollment
Spain
|
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=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
3 participants
n=24 Participants
|
4 participants
n=135 Participants
|
7 participants
n=136 Participants
|
|
Region of Enrollment
France
|
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=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
6 participants
n=135 Participants
|
6 participants
n=136 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=10 Participants
|
6 participants
n=115 Participants
|
13 participants
n=24 Participants
|
8 participants
n=42 Participants
|
8 participants
n=42 Participants
|
10 participants
n=42 Participants
|
8 participants
n=42 Participants
|
8 participants
n=36 Participants
|
10 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
104 participants
n=136 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks in Part A and Part B, and up to 3 months in Part CNumber of Treatment Emergent Adverse Events (TEAEs), as assessed by medDRA (v25).
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=3 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
n=13 Participants
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
n=8 Participants
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
n=8 Participants
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
n=10 Participants
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
n=8 Participants
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
n=8 Participants
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
n=10 Participants
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
n=12 Participants
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
n=16 Participants
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Emergent Adverse Events (TEAEs)
|
2 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
10 Participants
|
8 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 24 hoursObserved maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part A
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=2 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=4 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
n=3 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Maximum Concentration (Cmax) - Part A
|
6.82 pg/mL
Standard Deviation 2.19
|
11.4 pg/mL
Standard Deviation 4.32
|
24.1 pg/mL
Standard Deviation 8.18
|
26.3 pg/mL
Standard Deviation 4.79
|
28.5 pg/mL
Standard Deviation 10.8
|
57.4 pg/mL
Standard Deviation 28.7
|
37.5 pg/mL
Standard Deviation 11.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 14Population: Data not collected for a few subjects (missing data or site error)
Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part B
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=4 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Maximum Concentration (Cmax) - Part B
Day 1
|
20.6 pg/mL
Standard Deviation 3.43
|
19.6 pg/mL
Standard Deviation 5.68
|
23.8 pg/mL
Standard Deviation 8.97
|
42.9 pg/mL
Standard Deviation 30.3
|
124 pg/mL
Standard Deviation 105
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Maximum Concentration (Cmax) - Part B
Day 14
|
18.4 pg/mL
Standard Deviation 5.37
|
18.3 pg/mL
Standard Deviation 6.78
|
23.6 pg/mL
Standard Deviation 5.50
|
44.9 pg/mL
Standard Deviation 17.9
|
63.5 pg/mL
Standard Deviation 28.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 14, Day 28, Day 84Population: One (1) subject dropped out in Cohort 2 prior to the extension phase and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). In addition, data not collected for a few subjects (missing data or site error). PK data was not collected in Cohort 1 on Day 84 per the protocol at the time. The protocol was updated following completion of Cohort 1 to collect PK information in Cohort 2 on Day 84.
Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part C.
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=12 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=16 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Maximum Concentration (Cmax) - Part C
Day 1
|
21.3 pg/mL
Standard Deviation 9.20
|
11.9 pg/mL
Standard Deviation 7.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Maximum Concentration (Cmax) - Part C
Day 14
|
22.3 pg/mL
Standard Deviation 11.7
|
10.4 pg/mL
Standard Deviation 7.73
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Maximum Concentration (Cmax) - Part C
Day 28
|
18.4 pg/mL
Standard Deviation 7.42
|
21.5 pg/mL
Standard Deviation 17.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Maximum Concentration (Cmax) - Part C
Day 84
|
—
|
89.9 pg/mL
Standard Deviation 63.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hoursArea under the plasma-drug concentration time curve (AUC) (pg\*h/mL) in Part A
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=2 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=4 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
n=3 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma-drug Concentration Time Curve (AUC) - Part A
|
0.399 pg*h/mL
Standard Deviation 0.032
|
5.20 pg*h/mL
Standard Deviation 3.38
|
9.55 pg*h/mL
Standard Deviation 4.12
|
10.4 pg*h/mL
Standard Deviation 13.4
|
16.8 pg*h/mL
Standard Deviation 14.7
|
26.1 pg*h/mL
Standard Deviation 16.4
|
31.7 pg*h/mL
Standard Deviation 12.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 14Population: Data not collected for a few subjects (missing data or site error).
Area Under the Plasma-drug Concentration Time Curve (AUC) (pg\*h/mL) in Part B
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=4 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma-drug Concentration Time Curve (AUC) - Part B
Day 1
|
3.26 pg*h/mL
Standard Deviation 3.20
|
7.69 pg*h/mL
Standard Deviation 5.52
|
15.8 pg*h/mL
Standard Deviation 11.5
|
43.3 pg*h/mL
Standard Deviation 18.1
|
64.2 pg*h/mL
Standard Deviation 56.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-drug Concentration Time Curve (AUC) - Part B
Day 14
|
2.02 pg*h/mL
Standard Deviation 2.41
|
4.63 pg*h/mL
Standard Deviation 3.29
|
12.5 pg*h/mL
Standard Deviation 4.75
|
58.8 pg*h/mL
Standard Deviation 30.3
|
51.9 pg*h/mL
Standard Deviation 51.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 14, Day 28, Day 84Population: One (1) subject dropped out in Cohort 2 prior to the extension phase and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). In addition, data not collected for a few subjects (missing data or site error). Pharmacokinetic (PK) data was not collected in Cohort 1 on Day 84 per the protocol at the time. The protocol was updated following completion of Cohort 1 to collect PK information in Cohort 2 on Day 84.
Area Under the Plasma-drug Concentration Time Curve (AUC) (pg\*h/mL) in Part C.
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=12 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=16 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma-drug Concentration Time Curve (AUC) - Part C
Day 1
|
11.9 pg*h/mL
Standard Deviation 9.53
|
4.90 pg*h/mL
Standard Deviation 4.87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-drug Concentration Time Curve (AUC) - Part C
Day 14
|
16.1 pg*h/mL
Standard Deviation 14.0
|
3.99 pg*h/mL
Standard Deviation 4.22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-drug Concentration Time Curve (AUC) - Part C
Day 28
|
12.7 pg*h/mL
Standard Deviation 7.58
|
11.8 pg*h/mL
Standard Deviation 11.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-drug Concentration Time Curve (AUC) - Part C
Day 84
|
—
|
116 pg*h/mL
Standard Deviation 111
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hoursLevels of calcium corrected for albumin (mg/dL) in Part A
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=3 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
n=13 Participants
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Calcium Corrected for Albumin - Part A
|
9.700 mg/dL
Standard Deviation 0.0800
|
9.375 mg/dL
Standard Deviation 0.6215
|
9.688 mg/dL
Standard Deviation 0.3448
|
9.782 mg/dL
Standard Deviation 0.4303
|
10.065 mg/dL
Standard Deviation 0.2934
|
10.293 mg/dL
Standard Deviation 0.5258
|
10.195 mg/dL
Standard Deviation 0.2601
|
9.634 mg/dL
Standard Deviation 0.3030
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours, Day 14Population: One (1) subject in Cohort B4 discontinued from the study.
Levels of calcium corrected for albumin (mg/dL) in Part B
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
n=10 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Calcium Corrected for Albumin - Part B
24 hours
|
9.818 mg/dL
Standard Deviation 0.3283
|
9.661 mg/dL
Standard Deviation 0.3492
|
10.121 mg/dL
Standard Deviation 0.4320
|
10.01 mg/dL
Standard Deviation 0.30
|
10.01 mg/dL
Standard Deviation 0.41
|
9.68 mg/dL
Standard Deviation 0.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Calcium Corrected for Albumin - Part B
Day 14
|
9.586 mg/dL
Standard Deviation 0.3173
|
9.650 mg/dL
Standard Deviation 0.2081
|
10.055 mg/dL
Standard Deviation 0.5916
|
10.06 mg/dL
Standard Deviation 0.59
|
10.94 mg/dL
Standard Deviation 0.97
|
9.79 mg/dL
Standard Deviation 0.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 14, Day 28 and Day 84Population: One (1) subject dropped out in Cohort 2 prior to the extension phase. In addition to this subject, two (2) subjects from Cohort 1 and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). In addition, data not collected for a few subjects (missing data or site error).
Levels of calcium corrected for albumin (mg/dL) in Part C.
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=12 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=16 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Calcium Corrected for Albumin - Part C
Day 1 (hour 0)
|
8.44 mg/dL
Standard Deviation 0.420
|
8.61 mg/dL
Standard Deviation 0.552
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Calcium Corrected for Albumin - Part C
Day 14
|
8.48 mg/dL
Standard Deviation 0.537
|
8.38 mg/dL
Standard Deviation 0.726
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Calcium Corrected for Albumin - Part C
Day 28
|
8.64 mg/dL
Standard Deviation 0.491
|
8.537 mg/dL
Standard Deviation 0.697
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Calcium Corrected for Albumin - Part C
Day 84
|
7.95 mg/dL
Standard Deviation 0.817
|
8.73 mg/dL
Standard Deviation 0.878
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hoursSerum phosphate levels (mg/dL) in Part A
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=3 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
n=6 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
n=13 Participants
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Phosphate - Part A
|
3.353 mg/dL
Standard Deviation 0.6646
|
2.882 mg/dL
Standard Deviation 0.3884
|
3.840 mg/dL
Standard Deviation 0.5135
|
3.287 mg/dL
Standard Deviation 0.5021
|
3.908 mg/dL
Standard Deviation 0.5051
|
3.673 mg/dL
Standard Deviation 0.4975
|
3.417 mg/dL
Standard Deviation 0.4133
|
3.641 mg/dL
Standard Deviation 0.3637
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 14Population: One (1) subject in Cohort B4 discontinued from the study.
Serum phosphate levels (mg/dL) in Part B
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
n=8 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
n=10 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Phosphate - Part B
Day 1
|
3.616 mg/dL
Standard Deviation 0.1919
|
3.751 mg/dL
Standard Deviation 0.3229
|
3.824 mg/dL
Standard Deviation 0.5421
|
3.518 mg/dL
Standard Deviation 0.3332
|
3.398 mg/dL
Standard Deviation 0.3965
|
3.65 mg/dL
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Phosphate - Part B
Day 14
|
3.601 mg/dL
Standard Deviation 0.2299
|
3.850 mg/dL
Standard Deviation 0.3397
|
3.603 mg/dL
Standard Deviation 0.4738
|
3.727 mg/dL
Standard Deviation 0.3970
|
3.553 mg/dL
Standard Deviation 0.6037
|
3.74 mg/dL
Standard Deviation 0.40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (H0), Day 14 (H2), Day 28 (H2) and Day 84 (H2)Population: One (1) subject dropped out in Cohort 2 prior to the extension phase. In addition to this subject, two (2) subjects from Cohort 1 and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). For this reason, data was collected in ten (10) subjects in Cohort 1 and fourteen (14) subjects in Cohort 2 on Day 84. In addition, data not collected for a few subjects (missing data or site error).
Serum phosphate levels (mg/dL) in Part C.
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=12 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=16 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Phosphate - Part C
Day 1
|
4.12 mg/dL
Standard Deviation 0.798
|
4.53 mg/dL
Standard Deviation 0.780
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Phosphate - Part C
Day 14
|
3.43 mg/dL
Standard Deviation 0.742
|
3.95 mg/dL
Standard Deviation 0.849
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Phosphate - Part C
Day 28
|
3.50 mg/dL
Standard Deviation 0.843
|
3.82 mg/dL
Standard Deviation 0.868
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Phosphate - Part C
Day 84
|
3.60 mg/dL
Standard Deviation 0.589
|
3.80 mg/dL
Standard Deviation 6.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 and Day 43Population: * One (1) subject dropped out in Cohort 2 prior to the extension phase. In addition to this subject, two (2) subjects from Cohort 1 and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). For this reason, data was collected in ten (10) subjects in Cohort 1 and fourteen (14) subjects in Cohort 2 on Day 84. * On Day 84, one (1) patient in Cohort 1 was mistakenly given vitamin D. This patient is included in the nine (9) patients taking no vit D on Day 84.
Daily dose of oral calcium and active vitamin D for patients treated in Part C.
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=12 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=16 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Daily Dose of Oral Calcium and Active Vitamin D - Part C
Number of patients taking =< 500 mg/day of calcium on Day 28
|
9 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daily Dose of Oral Calcium and Active Vitamin D - Part C
Number of patients taking =< 500 mg/day of calcium on Day 84
|
8 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daily Dose of Oral Calcium and Active Vitamin D - Part C
Number of patients taking no vitamin D on Day 28
|
10 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daily Dose of Oral Calcium and Active Vitamin D - Part C
Number of patients taking no vitamin D on Day 84
|
9 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 14, Day 28 and Day 84Population: One (1) subject dropped out in Cohort 2 prior to the extension phase. In addition to this subject, two (2) subjects from Cohort 1 and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). For this reason, data was collected in ten (10) subjects in Cohort 1 and fourteen (14) subjects in Cohort 2 on Day 84. In addition, data not collected for a few subjects (missing data or site error).
24 hour calcium excretion rate (mg/24h) in Part C.
Outcome measures
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=12 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=16 Participants
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Calcium Excretion Rate 24h- Part C
Day 1
|
328.72 mg/24h
Standard Deviation 130.950
|
330.73 mg/24h
Standard Deviation 189.154
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Calcium Excretion Rate 24h- Part C
Day 14
|
224.83 mg/24h
Standard Deviation 108.570
|
188.41 mg/24h
Standard Deviation 100.054
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Calcium Excretion Rate 24h- Part C
Day 28
|
155.06 mg/24h
Standard Deviation 61.705
|
166.43 mg/24h
Standard Deviation 96.637
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Calcium Excretion Rate 24h- Part C
Day 84
|
115.70 mg/24h
Standard Deviation 37.929
|
145.15 mg/24h
Standard Deviation 113.563
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A (Cohort A1, 5 ug Dose)
Part A (Cohort A2, 10 ug Dose)
Part A (Cohort A3, 20 ug Dose)
Part A (Cohort A4, 40 ug Dose)
Part A (Cohort A5, 60 ug Dose)
Part A (Cohort A6, 120 ug Dose)
Part A (Cohort A7, 90 ug Dose)
Part A (Placebo)
Part B (Cohort B1, 10 ug Doses)
Part B (Cohort B2, 20 ug Doses)
Part B (Cohort B3, 40 ug Doses)
Part B (Cohort B4, 60 ug Doses)
Part B (Cohort B5, 80 ug Doses)
Part B (Placebo)
Part C (Cohort C1, Starting Dose of 20 ug/Day)
Part C (Cohort C2, Starting Dose of 10 ug/Day)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A (Cohort A1, 5 ug Dose)
n=3 participants at risk
Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1.
|
Part A (Cohort A2, 10 ug Dose)
n=6 participants at risk
Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1.
|
Part A (Cohort A3, 20 ug Dose)
n=6 participants at risk
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1.
|
Part A (Cohort A4, 40 ug Dose)
n=6 participants at risk
Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1.
|
Part A (Cohort A5, 60 ug Dose)
n=6 participants at risk
Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1.
|
Part A (Cohort A6, 120 ug Dose)
n=6 participants at risk
Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1.
|
Part A (Cohort A7, 90 ug Dose)
n=6 participants at risk
Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1.
|
Part A (Placebo)
n=13 participants at risk
Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1.
|
Part B (Cohort B1, 10 ug Doses)
n=8 participants at risk
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B2, 20 ug Doses)
n=8 participants at risk
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B3, 40 ug Doses)
n=10 participants at risk
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B4, 60 ug Doses)
n=8 participants at risk
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Cohort B5, 80 ug Doses)
n=8 participants at risk
Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14.
|
Part B (Placebo)
n=10 participants at risk
Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14.
|
Part C (Cohort C1, Starting Dose of 20 ug/Day)
n=12 participants at risk
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
Part C (Cohort C2, Starting Dose of 10 ug/Day)
n=16 participants at risk
Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
23.1%
3/13 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
4/16 • Number of events 4 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Vessel puncture site hematoma
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
37.5%
3/8 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
20.0%
2/10 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Ear and labyrinth disorders
Motion Sickness
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Ear and labyrinth disorders
Otorrhea
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Eye disorders
Asthenophenia
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
20.0%
2/10 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
20.0%
2/10 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Bowel Movement Irregularity
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
20.0%
2/10 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
20.0%
2/10 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
30.0%
3/10 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Gastrointestinal Sounds Abdominal
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
66.7%
4/6 • Number of events 4 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
50.0%
3/6 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
62.5%
5/8 • Number of events 11 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
50.0%
4/8 • Number of events 5 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
30.0%
3/10 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
37.5%
3/8 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Administration site hematoma
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Application site irritation
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
application site pruritis
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
asthenia
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Catheter site hematoma
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Catheter site irritation
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Catheter Site Pain
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
30.0%
3/10 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Catheter Site Swelling
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Chest Pain
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Feeling hot
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Hunger
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Injection Site Bruising
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Injection Site Erythema
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
33.3%
2/6 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
40.0%
4/10 • Number of events 7 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
37.5%
3/8 • Number of events 7 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 5 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
31.2%
5/16 • Number of events 7 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Injection Site Hematoma
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
37.5%
3/8 • Number of events 5 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
50.0%
5/10 • Number of events 11 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
37.5%
3/8 • Number of events 5 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
37.5%
3/8 • Number of events 7 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
30.0%
3/10 • Number of events 4 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
2/16 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Injection Site Pain
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
33.3%
2/6 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
30.8%
4/13 • Number of events 4 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Injection Site Pruritis
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
30.0%
3/10 • Number of events 4 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Injection Site Reaction
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
2/16 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Injection Site Swelling
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Peripheral Swelling
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Puncture site erythema
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Odema Peripheral
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
33.3%
2/6 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
General disorders
Thirst
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Investigations
Transaminases increased
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
2/16 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Investigations
Urine calcium/creatine ratio increased
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Investigations
Vitamin D increased
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
50.0%
3/6 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
33.3%
2/6 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
3/12 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
2/16 • Number of events 7 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
4/16 • Number of events 8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
2/16 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
20.0%
2/10 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
4/16 • Number of events 6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
40.0%
4/10 • Number of events 6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
2/12 • Number of events 4 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Nervous system disorders
headache
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
50.0%
3/6 • Number of events 4 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
33.3%
2/6 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
20.0%
2/10 • Number of events 4 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
50.0%
4/8 • Number of events 12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
30.0%
3/10 • Number of events 5 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
2/12 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
4/16 • Number of events 5 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Nervous system disorders
Hypoasthesia
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
2/16 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
66.7%
4/6 • Number of events 4 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
30.0%
3/10 • Number of events 8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
37.5%
3/8 • Number of events 11 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
16.7%
1/6 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Renal and urinary disorders
Hypercalciuria
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Skin and subcutaneous tissue disorders
Sensitive Skin
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
25.0%
2/8 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
20.0%
2/10 • Number of events 2 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
6.2%
1/16 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
12.5%
1/8 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/12 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/6 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/13 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/8 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/10 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
8.3%
1/12 • Number of events 1 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
0.00%
0/16 • Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
|
Additional Information
Senior VP of Clinical Development and Regulatory Affairs
Amolyt Pharma
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place