Recruiting
Phase 1

BIIB145

Sponsor:

Biogen

Code:

NCT07225517

Conditions

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

BIIB145

Placebo

Study Details

Brief summary:

In this study, researchers will learn for the first time about the safety of a study drug called BIIB145 and how the body responds to it. This is a "Phase 1" study. This kind of study is an early step in clinical research where the goal is to focus on the safety of the study drug. Another goal may be to learn how the study drug is processed by the body. BIIB145 was designed to help people with multiple sclerosis (MS). But, before it can be tested in people with MS, it must first be tested in healthy volunteers to learn about its safety and other effects.

The main goal of this study is to learn about the safety of BIIB145 and how it is processed by the body, with or without food.

The main questions researchers want to answer are:

  • How many participants have adverse events and serious adverse events during the study? An adverse event is a health problem that may or may not be caused by the study drug.
  • How does BIIB145 affect the participants' overall health?

Researchers will also learn more about:

  • How BIIB145 is processed by the body, with or without food.

This study will be done as follows:

  • Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into the study research center.
  • There will be 3 parts to this study.
  • Part 1: Participants will take a single dose of BIIB145 or a placebo after not eating overnight. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. Participants in Part 1 will be in the study for up to 42 days.
  • Part 2: This part of the study will have a "crossover" design. This means that all participants in Part 2 will all take BIIB145 twice, once with food and once without food. When taken with food, they will finish a meal about 30 minutes before their dose. Without food, they will not eat overnight before taking their dose. But, the order in which they take BIIB145 with or without food depends on the group to which they are randomly assigned. Participants in Part 2 will be in the study for up to 56 days.
  • Part 3: Participants will take a dose of BIIB145 or the placebo once a day for 14 days. For each dose, participants will not eat overnight before taking it. Participants in Part 3 will be in the study for up to 56 days.
  • For Part 1, participants will stay at the study research center for 4 days after screening. There will be 2 other visits to the center to check on participants' health on Day 7 and Day 14.
  • For Part 2, at 2 different times, participants will stay at the center for a period of 4 days at a time, after screening. There will be a break of about 7 days between stays. There will be 3 other visits to the center to check on their health on Day 7 (of each period) and on Day 14.
  • For Part 3, participants will stay at the center for 17 days after screening. There will be 2 other visits to the center to check on their health on Day 21 and Day 28.

Conditions

Healthy Volunteer

Study ID

NCT07225517

Start date

Dec 18, 2025

Status verified date

Feb, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A [Single Ascending Dose (SAD)]: BIIB145 Cohort 1A

Participants will receive Dose A of BIIB145 or a matching placebo on Day 1 in a fasted state.

experimental: Part A (SAD): BIIB145 Cohort 2A

Participants will receive Dose B of BIIB145 or a matching placebo on Day 1 in a fasted state.

experimental: Part A (SAD): BIIB145 Cohort 3A

Participants will receive Dose C of BIIB145 or a matching placebo on Day 1 in a fasted state.

experimental: Part A (SAD): BIIB145 Cohort 4A

Participants will receive Dose D of BIIB145 or a matching placebo on Day 1 in a fasted state.

experimental: Part A (SAD): BIIB145 Cohort 5A

Participants will receive Dose E of BIIB145 or a matching placebo on Day 1 in a fasted state.

experimental: Part A (SAD): BIIB145 Cohort 6A

Participants will receive Dose F of BIIB145 or a matching placebo on Day 1 in a fasted state.

experimental: Part A (SAD): BIIB145 Cohort 7A

Participants will receive Dose G of BIIB145 or a matching placebo on Day 1 in a fasted state.

experimental: Part B [Food Effect]: BIIB145 Cohort 1B

Participants will receive BIIB145 on Day 1 in the fasted state, followed by the fed state in the first sequence, and vice versa in the second sequence. A washout period of 7 days will be maintained between the two sequences. Dose will be determined based on safety and PK data of SAD Cohort 6A as well as safety, PK and pharmacodynamics (PD) data from previous cohorts.

experimental: Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 1C

Participants will receive Dose B of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state.

experimental: Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 2C

Participants will receive Dose C of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state.

experimental: Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 3C

Participants will receive Dose H of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state.

experimental: Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 4C

Participants will receive Dose F of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state.

Interventions

BIIB145

Administered orally

Placebo

Administered orally

Primary outcome measure

  • Parts A, B, and C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: 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 Abnormalities [ Time Frame: Parts 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 Parameters [ Time Frame: Parts 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) Events [ Time Frame: Part C: Up to Day 28 ]
  • Parts A, B, and C: Number of Participants With Potentially Clinically Relevant Abnormalities in 12-lead Electrocardiogram (ECG) Parameters [ Time Frame: Parts A and B: Up to Day 14; Part C: Up to Day 28 ]

Central Contacts and Locations

Central contacts

US Biogen Clinical Trial Center

866-633-4636clinicaltrials@biogen.com

Global Biogen Clinical Trial Center

clinicaltrials@biogen.com

Locations

PPD Austin Clinic

Recruiting

Austin, Texas, United States, 78744

Contacts

512-747-1870

Principal Investigator:

Jia Chang

More Information

Sponsor

Biogen

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Biogen on 2026-02-06.