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 developed by Biogen Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed.
BIIB107 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen sponsored the Phase 1 study of the compound in healthy adult participants.
BIIB107 is in Phase 1 development. Its single recorded clinical trial, NCT04593121, was a Phase 1 study that has been completed. The drug is investigational and is not approved for any indication.
BIIB107 has been evaluated in one clinical trial, NCT04593121, titled a Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants. The Phase 1 trial enrolled 84 participants in the United States and is completed.
The Phase 1 trial of BIIB107, NCT04593121, was a randomized, double-blind, controlled study in healthy adult volunteers aged 18 years and older. It enrolled 84 participants across sites in the United States and assessed safety, tolerability, pharmacokinetics and pharmacodynamics. The study is completed.