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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06444178 | Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants | PHASE1 | COMPLETED | 224 | — | — | Sep 30, 2024 | Jul 9, 2025 | Jul 16, 2025 | 1 | United Kingdom |
| NCT05102136 | Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 in Adult Healthy Volunteers | PHASE1 | COMPLETED | 56 | — | — | Oct 27, 2021 | Apr 4, 2023 | May 3, 2023 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Arm 1: Aspirin | ACTIVE_COMPARATOR | Randomized 1:1:1:1 |
| Arm 2: Aspirin + REGN9933 | EXPERIMENTAL | Randomized 1:1:1:1 |
| Arm 3: Aspirin + REGN7508 | EXPERIMENTAL | Randomized 1:1:1:1 |
| Arm 4: Aspirin + Rivaroxaban | ACTIVE_COMPARATOR | Randomized 1:1:1:1 |
| Intravenous Cohorts | EXPERIMENTAL | Randomized 6:2 to REGN9933 or placebo |
| Subcutaneous Cohorts | EXPERIMENTAL | Randomized 6:2 to REGN9933 or placebo |
| Name | Type | Description |
|---|---|---|
| Aspirin | DRUG | Oral administration |
| REGN9933 | DRUG | Administered intravenous (IV) |
| REGN7508 | DRUG | Administered IV |
| Rivaroxaban | DRUG | Oral administration |
| Placebo | DRUG | Placebo to match REGN9933 in same form; placebo administered IV or SC per the protocol |
Key Inclusion Criteria: 1. Body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit 2. Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to ...