Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05239221 | AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism | PHASE1 | COMPLETED | 132 | — | — | Sep 7, 2020 | Aug 23, 2022 | Sep 8, 2025 | 2 | Hungary, Netherlands |
Number of Treatment Emergent Adverse Events (TEAEs), as assessed by medDRA (v25).
| Arm | Type | Description |
|---|---|---|
| AZP-3601 | EXPERIMENTAL | subcutaneous (sc) administration once daily |
| Placebo (Parts A and B) | PLACEBO_COMPARATOR | subcutaneous (sc) administration once daily |
| Name | Type | Description |
|---|---|---|
| AZP-3601 | DRUG | Lyophilized powder of AZP-3601 to be reconstituted with water for injection before injection |
| Placebo | DRUG | Saline solution visually matching active medication |
Main inclusion criteria * Part A: healthy male volunteers aged 18 to 60 years old inclusive with a body mass index of 19 to 28 kg/m2 * Part B: healthy male and female volunteers (non-child bearing potential) aged 18 to 60 years inclusive with a Body mass index of 19 to 28 kg/m2 * Part C: 1. Male...