Safety and how the body processes BIIB145 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 Phase 1, randomized, placebo-controlled trial gives single and multiple ascending doses of BIIB145 to healthy adult volunteers to characterize safety and tolerability. Investigators will record adverse events, vital signs, ECGs, and laboratory results while measuring the drug's pharmacokinetics and its enantiomers. A dedicated food-effect cohort will compare pharmacokinetics after dosing with and without a meal. The study is sponsored by Biogen and performed at the PPD Austin Clinic in Austin, Texas.

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, and a total body weight \> 50 kilograms (kg) at Screening and Check-In.
* Must be in good health as determined by the Investigator, based on medical history and Screening evaluations. Good health is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG), and clinical laboratory tests.

Key Exclusion Criteria:

* History of any clinically significant blood disorders or 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, or ongoing, malignant disease, including solid tumours and hematologic malignancies (except for basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 1 year prior to Check-In).
* History of uncontrolled bleeding, or any risk of bleeding that, in the opinion of the Investigator, is clinically significant.
* History of torsades de pointes or additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, or family history of long QT syndrome), in the opinion of the Investigator.
* Any values of coagulation parameters including international normalized ratio, prothrombin time, and activated partial thromboplastin time above upper limit of normal at Screening or Check-In.
* Systolic blood pressure \> 150 millimetres of mercury (mmHg) or \< 90 mmHg after resting for 5 minutes in the supine position at Screening and prior to dosing. If out of range, testing may be repeated once at Screening and once prior to dosing.
* Any live or attenuated immunization or vaccination given within 30 days prior to Check-In or planned to be given during the study period.
* Prior exposure to BIIB145 or any lymphocyte-depleting therapy or exposure to any lymphocyte-targeting therapy within 3 months prior to Check-In, or at least 5 half-lives or for the anticipated duration of the product's pharmacodynamics (PD) effects, whichever is longer.
* Known lumbar spine deformity, degenerative arthritis of the lumbar spine, history of lumbar spinal surgery, spinal infection, spinal mass or trauma, and/or known evidence on magnetic resonance imaging (MRI) contraindicating lumbar puncture (LP).

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

Where it's running

• PPD Austin Clinic
  Austin, Texas, United States Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pfizer medicine PF-08103402: how different doses are tolerated in healthy adults and adults with mild-to-moderate asthma

  This study tests how different amounts of PF-08103402 behave in the body and how well it is tolerated by healthy adults and adults with mild-to-moderate asthma.

  Recruiting at 2 sites Phase 1 Pfizer · New Haven, Connecticut and 1 other locations · NCT07660731

• Comparing how three adhesive dressings stay on the skin

  We will test how well three different self-adhesive dressings stick to and stay on the back of healthy adults.

  Recruiting Molnlycke Health Care AB · Schenefeld, Free and Hanseatic City of Hamburg · NCT07034014

• Focal muscle vibration to limit leg muscle weakness during reduced use

  This trial will see if a 10-day program of focal muscle vibration can limit strength loss in healthy adults whose one leg is temporarily unloaded.

  Recruiting Centre Hospitalier Universitaire de Saint Etienne · Saint-Etienne · NCT07021079

• Kidney responses to exercise in heat and whether vitamin B3 changes them.

  This project will test whether taking vitamin B3 changes how the kidneys respond when healthy, physically fit adults exercise in hot, humid conditions.

  Recruiting at 2 sites Early Phase 1 Beth Israel Deaconess Medical Center · Boston, Massachusetts and 1 other locations · NCT06983730

• Assessing the safety of inhaling xenon gas in healthy volunteers

  This study is testing if inhaling xenon gas is safe for healthy people to see if it could help in treating neurodegenerative diseases like Alzheimer's in the future.

  Recruiting Phase 1 General Biophysics LLC · Boston, Massachusetts · NCT06945614

• Brain responses to gentle ear stimulation measured with near-infrared light

  This one-visit test uses gentle ear stimulation and near-infrared head sensors to see how healthy adults' brains respond.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT06825364

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.