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Also known as BIIB133 (Dapirolizumab pegol)
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 monoclonal antibody developed by Biogen Inc. (ticker: BIIB). It has been studied in a Phase 1 clinical trial in healthy Japanese and Caucasian participants. The specific disease indications for BIIB133 have not been disclosed.
BIIB133 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen sponsored the Phase 1 study of BIIB133 conducted in the United States.
BIIB133 is in Phase 1 development. Its only recorded clinical trial, NCT04571424, was a Phase 1 study that has been completed. The trial enrolled 33 participants and evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics.
BIIB133 has been evaluated in one clinical trial, NCT04571424, titled a study to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of BIIB133 (dapirolizumab pegol) in healthy Japanese and Caucasian participants. The Phase 1 trial was completed, enrolled 33 participants, and was randomized, double-blind, and placebo-controlled.
Yes. BIIB133 is also known as dapirolizumab pegol. The two names refer to the same monoclonal antibody candidate, and the Phase 1 trial NCT04571424 lists it under both designations.
The BIIB133 Phase 1 trial, NCT04571424, was a randomized, double-blind, placebo-controlled study in healthy Japanese and Caucasian volunteers aged 18 years and older. It enrolled 33 participants in the United States and assessed safety, tolerability, pharmacokinetics, and pharmacodynamics. The study has been completed.