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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05291546 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants | PHASE1 | COMPLETED | 93 | — | — | Apr 13, 2022 | Apr 2, 2024 | Apr 15, 2024 | 2 | Belgium, Germany |
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Single ascending dose (SAD) of REGN9035 or matching placebo given by intravenous (IV) administration. |
| Part B | EXPERIMENTAL | Selected doses of REGN5381 or matching placebo given by IV administration followed by selected doses of REGN9035 and/or matching placebo via IV infusion |
| Name | Type | Description |
|---|---|---|
| REGN9035 | DRUG | Part A: Single dose administered by IV infusion on day 1. Part B: Selected doses administered by IV infusion on day 2 or 22. |
| REGN5381 | DRUG | Part B: Selected doses administered by IV infusion on day 1. |
| Placebo | OTHER | Part A: Single dose administered by IV infusion on day1. Part B: Single dose administered by IV infusion on day 1, day 2 and/or day 22. |
Key Inclusion Criteria: 1. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at the screening visit. 2. Normal or mildly elevated blood pressure as defined in the protocol. Key Exclusion Criteria: 1. History of unexplained syncope or autonomic dysfunction. 2. History of clinically signifi...