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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03530514 | A Study to Examine the Safety, Tolerability and Biological Effects of REGN4461 in Healthy Volunteers | PHASE1 | COMPLETED | 113 | — | — | Apr 24, 2018 | Jan 27, 2020 | Mar 9, 2020 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Part A: Single dose cohort 1 | EXPERIMENTAL | Cohort 1 will receive a single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 2 | EXPERIMENTAL | Cohort 2 will receive a sequential ascending single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 3 | EXPERIMENTAL | Cohort 3 will receive a sequential ascending single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 4 | EXPERIMENTAL | Cohort 4 will receive a sequential ascending single SC dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 5 | EXPERIMENTAL | Cohort 5 will receive a sequential ascending single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 6 | EXPERIMENTAL | Cohort 6 will receive a sequential ascending single SC dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 7 | EXPERIMENTAL | Cohort 7 will receive a sequential ascending single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 8 | EXPERIMENTAL | Cohort 8 will receive a single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 9 | EXPERIMENTAL | Cohort 9 will receive a single IV dose of REGN4461 or matching placebo |
| Part B: Repeated dose cohort 10 | EXPERIMENTAL | Cohort 10 will receive repeated IV or SC doses of REGN4461 or matching placebo |
| Name | Type | Description |
|---|---|---|
| REGN4461 | DRUG | REGN4461 |
| Placebo | DRUG | Placebo-matching REGN4461 |
Key Inclusion Criteria Part A: * Males and females 18 to 50 years of age, inclusive * Body mass index (BMI) from 18.5 to \<30.0 kg/m\^2 * Participant is judged by the investigator to be in good health and free from major comorbidities based on medical history, physical examination, laboratory safe...