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).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

132 participants

Primary outcome timeframe

Up to 2 weeks in Part A and Part B, and up to 3 months in Part C

Results posted on

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

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

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

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 C

Number of Treatment Emergent Adverse Events (TEAEs), as assessed by medDRA (v25).

Outcome measures

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 hours

Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part A

Outcome measures

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 14

Population: 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

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 84

Population: 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

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 hours

Area under the plasma-drug concentration time curve (AUC) (pg\*h/mL) in Part A

Outcome measures

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 14

Population: 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

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 84

Population: 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

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 hours

Levels of calcium corrected for albumin (mg/dL) in Part A

Outcome measures

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 14

Population: One (1) subject in Cohort B4 discontinued from the study.

Levels of calcium corrected for albumin (mg/dL) in Part B

Outcome measures

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 84

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). 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

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 hours

Serum phosphate levels (mg/dL) in Part A

Outcome measures

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 14

Population: One (1) subject in Cohort B4 discontinued from the study.

Serum phosphate levels (mg/dL) in Part B

Outcome measures

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

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 43

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. * 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

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 84

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).

24 hour calcium excretion rate (mg/24h) in Part C.

Outcome measures

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)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Part A (Cohort A2, 10 ug Dose)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part A (Cohort A3, 20 ug Dose)

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Part A (Cohort A4, 40 ug Dose)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Part A (Cohort A5, 60 ug Dose)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part A (Cohort A6, 120 ug Dose)

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Part A (Cohort A7, 90 ug Dose)

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Part A (Placebo)

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Part B (Cohort B1, 10 ug Doses)

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Part B (Cohort B2, 20 ug Doses)

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Part B (Cohort B3, 40 ug Doses)

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Part B (Cohort B4, 60 ug Doses)

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Part B (Cohort B5, 80 ug Doses)

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Part B (Placebo)

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Part C (Cohort C1, Starting Dose of 20 ug/Day)

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Part C (Cohort C2, Starting Dose of 10 ug/Day)

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: +33 428 01 21 54

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place