BIIB142 safety and how the body handles it in healthy adults 18 to 55

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 dose-escalation trial gives single and repeated oral doses of BIIB142 or matching placebo to healthy adults aged 18–55 to measure safety, tolerability, and pharmacokinetics. After a screening period of up to 28 days, participants are enrolled into sequential dose cohorts with increasing doses until the highest tolerable dose is identified. Safety monitoring includes recording adverse events, vital signs, ECGs, and laboratory tests, while PK sampling characterizes absorption, distribution, metabolism, and excretion. The study is conducted at a single clinical research site with scheduled clinic visits and any required short-term confinement.

Why it matters

Who can join: the full rules

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 prior to randomization.
* Must be in good health as determined by the Investigator.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
* History of severe allergic or anaphylactic reactions
* History of or ongoing malignant disease (with limited exceptions)
* Systolic blood pressure \>150 millimeters of mercury (mmHg) or \<90 mmHg.
* Clinically significant (as determined by the Investigator) electrocardiogram (ECG) abnormalities.
* History of or positive test for human immunodeficiency virus (HIV).
* Chronic, recurrent, or serious infection within 90 days prior to Screening.
* Symptoms of bacterial, fungal, or viral infection within 14 days prior to Screening.
* Any live or attenuated immunization within 14 days prior to Screening.
* Use of prescription medications, over-the-counter medications that alter hepatic or renal clearance, or nutraceuticals within 28 days prior to Check-in.
* MAD Cohorts only: Suicidal ideation with some intent to act within 6 months prior to the start of Screening or history of suicidal behavior within one year prior to Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• PPD Development, LP
  Las Vegas, Nevada, United States Recruiting

Study contacts

• Study coordinator: US Biogen Clinical Trial Center
• Email: clinicaltrials@biogen.com
• Phone: 866-633-4636

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.