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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Medical Director · STUDY_DIRECTOR · Biogen
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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