Phase 1 Study of BIIB145 for Multiple Sclerosis
This study is looking for healthy adults to help researchers learn about a new drug called BIIB145, which is being developed for multiple sclerosis (MS). This is an early-stage study (Phase 1) focused on understanding if BIIB145 is safe and how your body processes it, both with and without food. Researchers will monitor for any side effects (adverse events), changes in lab tests, and vital signs to determine its safety. To join, you need to be between 18 and 55 years old, in good general health, and meet specific weight and body mass index (BMI) requirements. The study aims to enroll 104 participants.
- Study design
- This is an interventional Phase 1 study where participants will receive either BIIB145 or a placebo (an inactive substance) orally. It plans to enroll 104 healthy adult participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for safety up to 14 days in some parts of the study, and up to 28 days in others.
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NCT07225517
A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult Participants
Recruiting
PHASE1Ages 18–55InterventionalTreatmentBiogen
~104 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:BIIB145Placebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts A, B, and C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured over Parts A and Part B: Up to Day 14; Part C: Up to Day 28
+4 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Medical Director · STUDY_DIRECTOR · Biogen
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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).
What this trial measures
- Parts A, B, and C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Parts A and Part B: Up to Day 14; Part C: Up to Day 28
- Parts A, B, and C: Number of Participants With Clinical Laboratory AbnormalitiesParts A and Part B: Up to Day 14; Part C: Up to Day 28
- Parts A, B, and C: Number of Participants With Clinically Relevant Abnormalities in Vital Sign ParametersParts A and Part B: Up to Day 14; Part C: Up to Day 28
- Part C: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) EventsPart C: Up to Day 28
- Parts A, B, and C: Number of Participants With Potentially Clinically Relevant Abnormalities in 12-lead Electrocardiogram (ECG) ParametersParts A and B: Up to Day 14; Part C: Up to Day 28