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

A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB142 in Healthy Adults

This study will test whether BIIB142 is safe and how the body processes it in healthy adults aged 18 to 55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Biogen (Industry-sponsored)
• Locations: 1 site (Las Vegas, Nevada)
• Trial ID: NCT07133828 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Healthy adults aged 18 to 55 with BMI 18–32 kg/m2, weight ≥50 kg, a negative SARS‑CoV‑2 PCR at check‑in, and no significant medical history are the ideal candidates.

Not a fit: Individuals with significant cardiac, hepatic, renal, neurologic, psychiatric, immunologic, metabolic, or malignant disease, those with abnormal ECGs or blood pressure outside the allowed range, or other major health issues are unlikely to be eligible or receive benefit.

Why it matters

Potential benefit: If the drug proves safe and its behavior in the body is understood, the results could allow BIIB142 to move into patient trials and potentially become a future treatment option.

How similar studies have performed: First‑in‑human single and multiple ascending dose safety and PK studies are a standard and often-successful step in drug development, although BIIB142 itself is a novel compound with no prior human data.

Eligibility criteria

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 this trial is running

Las Vegas, Nevada

• PPD Development, LP — Las Vegas, Nevada, United States (Recruiting)

Study contacts

• Study coordinator: US Biogen Clinical Trial Center

Conditions Healthy Volunteer