Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIIB107 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a patient or clinical investigation 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 (including an abnormal laboratory finding), 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 congenital anomaly/birth defect, or is a medically important event.
An AE is any untoward medical occurrence in a patient or clinical investigation 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 (including an abnormal laboratory finding), 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 congenital anomaly/birth defect, or is a medically important event.
| Arm | Type | Description |
|---|---|---|
| Cohort 1A | EXPERIMENTAL | Participants will receive Dose 1 of BIIB107 or placebo subcutaneous (SC) on Day 1. |
| Cohort 2A | EXPERIMENTAL | Participants will receive Dose 2 of BIIB107 or placebo SC on Day 1. |
| Cohort 3A | EXPERIMENTAL | Participants will receive Dose 3 of BIIB107 or placebo SC on Day 1. |
| Cohort 4A | EXPERIMENTAL | Participants will receive Dose 4 of BIIB107 or placebo SC on Day 1. |
| Cohort 7A | EXPERIMENTAL | Participants will receive Dose 5 of BIIB107 or placebo SC on Day 1. |
| Cohort 5A | EXPERIMENTAL | Participants will receive Dose 5 of BIIB107 or placebo intravenous (IV) on Day 1. |
| Cohort 8A | EXPERIMENTAL | Participants will receive Dose 6 of BIIB107 or placebo SC on Day 1. |
| Cohort 1B | EXPERIMENTAL | Participants will receive multiple doses of BIIB107 or placebo SC on approximately 4 dosing days. |
| Cohort 2B | EXPERIMENTAL | Participants will receive multiple doses of BIIB107 or placebo SC on approximately 4 dosing days. |
| Name | Type | Description |
|---|---|---|
| BIIB107 | DRUG | Administered as specified in the treatment arm. |
| Placebo | DRUG | Administered as specified in the treatment arm. |
Key Inclusion Criteria: * Must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2), inclusive, and must weigh at least 55 kilogram (kg) * All women of childbearing potential must practice highly effective contraception during the study and for a period of 90 days, whi...
BIIB107 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 adult participants. BIIB107 is not approved for any indication and remains in early-stage clinical testing.
BIIB107 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. Biogen is conducting clinical research on BIIB107 as an investigational small molecule, with the drug currently in Phase 1 development.
BIIB107 is in Phase 1 clinical development. The drug has completed one Phase 1 trial, which enrolled 84 healthy adult participants in the United States. BIIB107 is an investigational agent and has not been approved by regulatory authorities.
BIIB107 has one completed clinical trial, registered under NCT04593121. This Phase 1 study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of BIIB107 in healthy adult participants. The trial enrolled 84 participants in the United States and was a randomized, double-blind, controlled study.
BIIB107 is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development. The drug has completed an early-stage trial in healthy volunteers, but it has not received regulatory approval for any medical use.