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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04571424 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian Participants | PHASE1 | COMPLETED | 33 | — | — | Oct 14, 2020 | Apr 8, 2021 | Apr 18, 2023 | 1 | United States |
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a birth defect.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: BIIB133 Dose 1 | EXPERIMENTAL | Participants will receive single IV infusion of BIIB133 Dose 1. |
| Cohort 2: BIIB133 Dose 2 | EXPERIMENTAL | Participants will receive single IV infusion of BIIB133 Dose 2. |
| Cohort 1-2: Placebo | PLACEBO_COMPARATOR | Participants will receive single IV infusion of matching placebo to BIIB133. |
| Name | Type | Description |
|---|---|---|
| BIIB133 (Dapirolizumab pegol) | DRUG | Administered as specified in the treatment arm |
| Placebo | DRUG | Administered as specified in the treatment arm |
Key Inclusion Criteria: * Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 14 days of Day -1 (inclusive). * Japanese study participant has both biological parents and all 4 grandparents of Japanese descent and, if living ou...