A Study on the Safety of BIIB142 in Healthy Adults

This study is looking for healthy adults aged 18 to 55 to help researchers learn about BIIB142. This is the first time BIIB142 will be given to people. The main goal is to understand how safe BIIB142 is and how your body processes it. Researchers will be carefully watching for any health problems, called adverse events (AEs), that might happen during the study. An AE is considered serious if it's life-threatening or requires hospital care. You would receive either BIIB142 or a matching placebo (an inactive substance). This is a dose escalation study, meaning different groups will receive increasing amounts of BIIB142. The study plans to enroll 78 participants. The current recruitment status is unclear.

Study design
This is an interventional study involving 78 healthy adult participants. Participants will receive either BIIB142 or a placebo orally.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants in Part A (SAD) will be followed for up to 15 days, and participants in Part B (MAD) will be followed for up to 29 days.

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NCT07133828

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

Recruiting
PHASE1Ages 18–55InterventionalTreatment
Biogen
~78 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:BIIB142BIIB142-Matching Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured over Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
+4 more outcomes measured
Healthy Volunteer
1 sites across 1 states
Nevada1
  • Medical Director · STUDY_DIRECTOR · Biogen

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Eligibility criteria

Inclusion

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.

Exclusion

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.
  • 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 AbnormalitiesPart A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
  • Number of Participants with Potentially Clinically Relevant Abnormalities in Vital Sign ParametersPart 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) ScorePart B (MAD): Up to Day 29
  • Number of Participants With Potentially Clinically Relevant Abnormalities in 12-lead Electrocardiogram (ECG) ParametersPart A (SAD): Up to Day 15; Part B (MAD): Up to Day 29