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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05505448 | A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants | PHASE1 | COMPLETED | 48 | — | — | Sep 15, 2022 | May 30, 2023 | Jul 27, 2023 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 Mid IV Dose | EXPERIMENTAL | Randomized 3:1 for single ascending dose |
| Cohort 2 Mid SC Dose | EXPERIMENTAL | Randomized 3:1 for single ascending dose |
| Cohort 3 High IV Dose | EXPERIMENTAL | Randomized 3:1 for single ascending dose |
| Cohort 4 High SC Dose | EXPERIMENTAL | Randomized 3:1 for single ascending dose |
| Cohort 5 Higher IV Dose | EXPERIMENTAL | Randomized 3:1 for single ascending dose |
| Cohort 6 Highest IV Dose | EXPERIMENTAL | Randomized 3:1 for single ascending dose |
| Cohort 7 Low IV Dose | EXPERIMENTAL | Randomized 3:1 for single ascending dose |
| Cohort 8 Low SC Dose | EXPERIMENTAL | Randomized 3:1 for single ascending dose |
| Name | Type | Description |
|---|---|---|
| REGN14284 | DRUG | Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol |
| Matching Placebo | DRUG | Single ascending IV or SC administration per the protocol |
Key Inclusion Criteria: 1. Has SARS-CoV-2-negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol. 2. Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening 3....