Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIIB113 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a participant 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; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); 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.
C-SSRS is used to assess the suicidality of participants during the study. The assessment includes "yes" or "no" responses for 5 questions each, related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings are provided for severity of ideation, from 1 to 5, with 5 being the most severe.
| Arm | Type | Description |
|---|---|---|
| Part A [Single Ascending Dose (SAD)]: BIIB113 Cohort 1 | EXPERIMENTAL | Participants aged 18 to 64 years will receive Dose 1 of BIIB113, orally, once daily (QD), on Day 1 of Part A of the study. |
| Part A (SAD): BIIB113 Cohort 2 | EXPERIMENTAL | Participants aged 18 to 64 years will receive Dose 2 of BIIB113, orally, QD, on Day 1 of Part A of the study |
| Part A (SAD): BIIB113 Cohort 3 | EXPERIMENTAL | Participants aged 18 to 64 years will receive Dose 3 of BIIB113, orally, QD, on Day 1 of Part A of the study. |
| Part A (SAD): BIIB113 Cohort 4 | EXPERIMENTAL | Participants aged 18 to 64 years will receive Dose 4 of BIIB113, orally, QD, on Day 1 of Part A of the study. |
| Part A (SAD): BIIB113 Cohort 5 | EXPERIMENTAL | Participants aged 18 to 64 years will receive Dose 5 of BIIB113, orally, QD, on Day 1 of Part A of the study |
| Part A (SAD): BIIB113-Matching Placebo (Cohorts 1-5) | PLACEBO_COMPARATOR | Participants aged 18 to 64 years will receive BIIB113-matching placebo, orally, QD, on Day 1 of Part A of the study. |
| Part B [Multiple Ascending Dose (MAD)]: BIIB113 Cohort 6 | EXPERIMENTAL | Participants aged 18 to 64 years will receive Dose 3 of BIIB113, orally, QD, up to Day 14 of Part B of the study. |
| Part B (MAD): BIIB113 Cohort 7 | EXPERIMENTAL | Participants aged 18 to 64 years will receive Dose 4 of BIIB113, orally, QD, on Days 1 to 14 of Part B of the study. |
| Part B (MAD): BIIB113 Cohort 8 | EXPERIMENTAL | Participants aged 18 to 64 years will receive Dose 6 of BIIB113, orally, QD, on Days 1 to 14 of Part B of the study. |
| Part B (MAD): BIIB113 Cohort 9 | PLACEBO_COMPARATOR | Participants aged 65 to 75 years will receive BIIB113, orally, QD, on Days 1 to 14 of Part B of the study. The calculated dose level will be adaptive by design based on review of the safety, tolerability, and PK data from Cohorts 1 to 7. |
| Part B (MAD): BIIB113-Matching Placebo (Cohorts 6 to 9) | PLACEBO_COMPARATOR | Participants aged 18 to 75 will receive BIIB113-matching placebo, orally, QD, on Days 1 to 14 of Part B of the study. |
| Part C (OGA-PET SAD): BIIB113 | EXPERIMENTAL | Participants aged 20 to 64 will receive single dose of BIIB113, orally, QD, on Day 1 of Part C of the study, followed by a radiotracer specific to OGA (\[11\^C\]BIO-1819578), on Days 1 to 4 of Part C of the study. |
| Part C (OGA-PET MAD): BIIB113 | EXPERIMENTAL | Participants aged 20 to 64 years will receive multiple doses of BIIB113, orally, QD, on Days 1 to 14 of Part C of the study, followed by a radiotracer specific to OGA (\[11\^C\]BIO-1819578) on Day 1 and either of Day 15, Day 16 or Day 17 of Part C of the study. |
| Name | Type | Description |
|---|---|---|
| BIIB113 | DRUG | Administered as specified in the treatment arm. |
| BIIB113-Matching Placebo | DRUG | Administered as specified in the treatment arm. |
| 11^C]BIO-1819578 | DRUG | Administered as specified in the treatment arm. |
Key Inclusion Criteria: * Female or infertile/vasectomized males aged 18 to 64 years (Parts A and B), 20 to 64 years (Part C), or 65 to 75 years (Part B Dose 7Cohort 9 only), inclusive, at the time of informed consent * Have a body mass index between 18 and 32 kilograms per square meter (kg/m\^2), ...
BIIB113 is an investigational small molecule therapeutic being developed by Biogen Inc. It has been studied in a Phase 1 clinical trial in healthy volunteers. Its specific disease indication has not been publicly disclosed, and it remains in early clinical development.
BIIB113 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is the sponsor of the clinical program evaluating the compound.
BIIB113 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational agent and has not been approved by the FDA for any indication.
BIIB113 has been evaluated in a single Phase 1 trial, NCT05195008, titled a study to evaluate the safety, tolerability, and pharmacokinetics with target occupancy of BIIB113 in healthy participants. The trial enrolled 72 participants across Sweden and the United Kingdom and has been completed.
The Phase 1 trial NCT05195008 was a randomized, double-blind, placebo-controlled study of BIIB113 in healthy volunteers aged 18 years and older. It enrolled 72 participants in Sweden and the United Kingdom and assessed safety, tolerability, pharmacokinetics, and target occupancy. The study has been completed.