Safety test of a single dose of BIIB144 in healthy adults

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 first-in-human trial assesses the safety and tolerability of ascending single IV doses of BIIB144 versus placebo in healthy adults. It also characterizes how BIIB144 is absorbed, distributed, metabolized, and eliminated (pharmacokinetics). Participants are healthy volunteers with BMI 18–32 and no significant health conditions. The study prioritizes safety outcomes, including adverse events and serious adverse events, and collects PK data to inform dose selection for future studies.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 32 kilograms per square metre (kg/m\^2), inclusive, at Screening.
* Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.

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, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
* History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 1 year prior to Day -1).
* History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
* Any live or attenuated immunization or vaccination given within 14 days prior to Screening, between Screening and Day -1, or planned to be given during the study period.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Where it's running

• Las Vegas Clinical Research Unit, 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.