Safety and how the body processes BIIB145 in healthy adults

A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending-Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB145 in Healthy Adult Participants

This trial will test whether BIIB145 is safe and how the body absorbs, metabolizes, and clears it in healthy adults, including whether food changes those effects.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Biogen (Industry-sponsored)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT07225517 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Healthy adults in good medical condition with body mass index between 18 and 32 kg/m² and body weight over 50 kg who pass screening evaluations.

Not a fit: People with active medical conditions, a history of significant cardiac, hepatic, renal, hematologic, neurologic, psychiatric, or malignant disease, or those with abnormal screening tests are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If BIIB145 is shown to be safe with predictable pharmacokinetics, it could allow the drug to progress into trials in people with multiple sclerosis.

How similar studies have performed: This is the first human study of BIIB145; while Phase 1 healthy-volunteer studies are the normal path for many MS drugs, this specific compound has not been previously tested in humans.

Eligibility criteria

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 this trial is running

Austin, Texas

• PPD Austin Clinic — Austin, Texas, United States (Recruiting)

Study contacts

• Study coordinator: US Biogen Clinical Trial Center

Conditions Healthy Volunteer