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BIIB142

Phase 1

Undisclosed | Small molecule | Other |Biogen Inc.|Trials Updated: May 6, 2026

BIIB142 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2025

BIIB142 target and mechanism

Molecular targetIRAK4
Target classKinase
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

BIIB142 clinical trials

BIIB142 · 1 trial · 1 indication

Phase 1 1
NCT07133828A Study to Learn About the Safety of BIIB142 and How it is Processed in the Body of Healthy Adult Participants Aged 18 to 55 Years OldHealthy Volunteer
RECRUITING78 Analytics
PHASE1RECRUITING
A Study to Learn About the Safety of BIIB142 and How it is Processed in the Body of Healthy Adult Participants Aged 18 to 55 Years Old
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
Number of Participants with Clinical Laboratory Abnormalities
Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
Number of Participants with Potentially Clinically Relevant Abnormalities in Vital Sign Parameters
Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Part B (MAD): Up to Day 29
Number of Participants With Potentially Clinically Relevant Abnormalities in 12-lead Electrocardiogram (ECG) Parameters
Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29

Secondary Endpoints

Plasma Concentration of BIIB142
Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Area Under the Concentration-Time Curve (AUC) of BIIB142
Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Maximum Observed Concentration (Cmax) of BIIB142
Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A [Single Ascending Dose (SAD)]: BIIB142 Cohort 1AEXPERIMENTALParticipants will receive Dose A of BIIB142 or a matching placebo on Day 1 in a fasted state.
Part A (SAD): BIIB142 Cohort 2AEXPERIMENTALParticipants will receive Dose B of BIIB142 or a matching placebo on Day 1 in a fasted state.
Part A (SAD): BIIB142 Cohort 3AEXPERIMENTALParticipants will receive Dose C of BIIB142 or a matching placebo on Day 1 in a fasted state.
Part A (SAD): BIIB142 Cohort 4AEXPERIMENTALParticipants will receive Dose D of BIIB142 or a matching placebo on Day 1 in a fasted state.
Part A (SAD): BIIB142 Cohort 5AEXPERIMENTALParticipants will receive Dose E of BIIB142 or a matching placebo on Day 1 in a fasted state.
Part A (SAD): BIIB142 Cohort 6AEXPERIMENTALParticipants will receive BIIB142 on Day 1 in the fasted followed by fed state in the first sequence, and vice versa in the second sequence. A washout period of 14 days will be maintained between both the sequences. Dose will be determined based on emerging PK data.
Part B [Multiple Ascending Dose (MAD)]: BIIB142 Cohort 1BEXPERIMENTALParticipants will receive Dose A of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state.
Part B (MAD): BIIB142 Cohort 2BEXPERIMENTALParticipants will receive Dose F of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state.
Part B (MAD): BIIB142 Cohort 3BEXPERIMENTALParticipants will receive Dose D of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state.

Interventions

NameTypeDescription
BIIB142DRUGAdministered Orally
BIIB142-Matching PlaceboDRUGAdministered Orally
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Have a body mass index between 18 and 32 kilograms per square meter (kg/m\^2), inclusive, at screening. * Weight ≥ 50 kilograms (kg) at screening. * Negative polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in p...

Countries:United States
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Frequently asked questions about BIIB142

What is BIIB142?

BIIB142 is an investigational small molecule drug being developed by Biogen Inc. (ticker BIIB). It is in Phase 1 clinical development, and its intended therapeutic indications have not been disclosed. The only registered study to date is a safety and pharmacokinetic trial in healthy adult volunteers.

What does BIIB142 target?

BIIB142 targets IRAK4, a kinase. IRAK4 is the molecular target of this small molecule, which places BIIB142 in the kinase inhibitor class. Biogen is developing the compound, and it is currently in Phase 1 testing in healthy volunteers rather than in patients with a disclosed disease.

Who makes BIIB142?

Biogen Inc., which trades under the ticker BIIB, is developing BIIB142. Biogen is the sponsor of the compound's registered Phase 1 study. No other developer or partner is associated with BIIB142 in its registered clinical program.

What phase is BIIB142 in?

BIIB142 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any use. The program currently consists of a single Phase 1 study that is recruiting healthy adult participants aged 18 to 55 years in the United States.

What clinical trials is BIIB142 in?

BIIB142 is being studied in one Phase 1 trial, NCT07133828, titled a study to learn about the safety of BIIB142 and how it is processed in the body of healthy adult participants aged 18 to 55 years old. The trial is recruiting 78 healthy volunteers in the United States and is randomized, double-blind, and controlled.