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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03645746 | Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers | PHASE1 | COMPLETED | 56 | — | — | Aug 23, 2018 | Sep 30, 2019 | Nov 26, 2019 | 1 | Belgium |
As measured by chemistry, hematology and urinalysis
As measured by heart rate, blood pressure, body temperature and respiratory rate
As measured by heart rate, PR, complex of Q, R, and S waves \[QRS\], QT-intervals, and QTc
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1 will receive a single IV dose of REGN5069 or matching placebo |
| Cohort 2 | EXPERIMENTAL | Cohort 2 will receive a single sequential ascending IV dose of REGN5069 or matching placebo |
| Cohort 3 | EXPERIMENTAL | Cohort 3 will receive a single sequential ascending IV dose of REGN5069 or matching placebo |
| Cohort 4 | EXPERIMENTAL | Cohort 4 will receive a single sequential ascending IV dose of REGN5069 or matching placebo |
| Cohort 5 | EXPERIMENTAL | Cohort 5 will receive a single SC dose of REGN5069 or matching placebo |
| Cohort 6 | EXPERIMENTAL | Cohort 6 will receive a single sequential ascending SC dose of REGN5069 or matching placebo |
| Cohort 7 | EXPERIMENTAL | Cohort 7 will receive a single sequential ascending IV dose of REGN5069 or matching placebo |
| Name | Type | Description |
|---|---|---|
| REGN5069 | DRUG | REGN5069 will be administered by IV infusion or SC injection |
| Placebo | DRUG | Placebo-matching REGN5069 |
Key Inclusion Criteria: * Participant is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG performed at screening and/or prior to study drug dosing * Participant is in good health based on laboratory safety testing obtai...