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BIIB142

Phase 1

Healthy Volunteer | Small molecule | Other |Biogen Inc.|Last Updated: May 6, 2026

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

Clinical trial landscape

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
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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 used for?

BIIB142 is an investigational small molecule being studied in healthy volunteers. It is currently in a Phase 1 clinical trial to evaluate its safety and how it is processed in the body of healthy adult participants aged 18 to 55 years old. The drug is not approved for any condition and remains in clinical development.

Who makes BIIB142?

BIIB142 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting a Phase 1 clinical trial to assess the safety and pharmacokinetics of BIIB142 in healthy volunteers.

What phase is BIIB142 in?

BIIB142 is in Phase 1 clinical development. The ongoing trial is recruiting participants and is designed to study the safety of the drug and how it is processed in the body. As an investigational drug, BIIB142 has not been approved by regulatory authorities and is still in early-stage testing.

What clinical trials is BIIB142 in?

BIIB142 is being studied in one Phase 1 clinical trial with the identifier NCT07133828. This randomized, double-blind, controlled study is recruiting 78 healthy adult participants in the United States to evaluate the safety and processing of BIIB142 in the body.

Is BIIB142 FDA approved?

BIIB142 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is studying the safety and how the drug is processed in healthy volunteers, and it has not yet been evaluated for efficacy or submitted for regulatory approval.