A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult Participants

Part of paid clinical trials in Austin, Texas.

Sponsor
Biogen
Study ID
NCT07225517
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BIIB145 — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

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.

Key Dates

Start date
Dec 18, 2025
Status verified
Feb 2026
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PPD Austin ClinicAustinTexas78744
512-747-1870
Jia Chang (PRINCIPAL_INVESTIGATOR)

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By research site
PPD Austin Clinic· Austin, TX

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