Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIIB133 · 1 trial · 1 indication
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...
BIIB133 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy Japanese and Caucasian participants.
BIIB133 is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical research on this investigational small molecule.
BIIB133 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and other properties.
BIIB133 has one completed clinical trial, identified as NCT04571424. This Phase 1 study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of BIIB133 in healthy Japanese and Caucasian participants, with a total enrollment of 33 individuals.
The clinical trial for BIIB133, NCT04571424, is titled 'A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian Participants,' indicating that BIIB133 is also known as Dapirolizumab Pegol.