A Study to Learn More About the Safety of a Single Dose of BIIB144 and How it is Processed in the Body of Healthy Adult Participants Ages 18 to 55 Years Old as Compared to a Placebo

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
Biogen
Study ID
NCT07662148
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BIIB144 — DRUG
    Administered IV
  • Placebo — DRUG
    Administered IV

Study Details

In this study, researchers will learn how the body processes a study drug called BIIB144. This is a "first-in-human" study. This means that this study drug will be given to people for the first very time in this study. These studies are important because they help researchers learn about the safety of the study drug, how the body processes it, and what dose might be appropriate before testing it in larger groups. The main goal of this study is to learn more about the safety of a single dose of BIIB144 compared to a placebo. 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. The main question researchers want to answer in this study is: How many participants have adverse events (AEs) and serious adverse events (SAEs)? An AE is a health problem that may or may not be caused by the study drug. Researchers will also learn more about: * How the body processes BIIB144 compared to placebo. 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 eligible participants will check into their study research center. * Participants will stay at their study research center for about 8 days. Afterwards, they will have up to 13 visits to their study research center. * This will be a "dose escalation" study. In this kind of study, increasing amounts of study drug are given to different groups of participants. Usually, this is done until researchers find the highest dose that does not cause harmful effects. In this study, the number of dose groups and maximum dose are planned in advance. The dose escalation will stop once these planned groups are done or if safety concerns arise. * There will be a total of 6 groups. In each group, participants will receive a single dose of either BIIB144 or the placebo through an intravenous (IV) needle. * Throughout the study, participants will give blood and urine samples. Participants will also have physical exams and answer questions about how they are feeling. * Each participant will be in the study for up to 44 weeks.

Key Dates

First listed
Jun 23, 2026
Start date
Jul 21, 2026
Status verified
Jul 2026
Primary completion
Jun 19, 2028
Completion
Jun 19, 2028

Study Design

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

Arms

  • Experimental: BIIB144 Cohort 1
    Participants will receive Dose A of BIIB144 or a matching placebo via intravenous (IV) infusion on Day 1.
  • Experimental: BIIB144 Cohort 2
    Participants will receive Dose B of BIIB144 or a matching placebo via IV infusion on Day 1.
  • Experimental: BIIB144 Cohort 3
    Participants will receive Dose C of BIIB144 or a matching placebo via IV infusion on Day 1.
  • Experimental: BIIB144 Cohort 4
    Participants will receive Dose D of BIIB144 or a matching placebo via IV infusion on Day 1.
  • Experimental: BIIB144 Cohort 5
    Participants will receive Dose E of BIIB144 or a matching placebo via IV infusion on Day 1.
  • Experimental: BIIB144 Cohort 6
    Participants will receive Dose F of BIIB144 or a matching placebo via IV infusion on Day 1.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 280 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Las Vegas Clinical Research Unit, PPD Development, LPLas VegasNevada89113
702-963-1600
Aishwarya Vyas Lahar (PRINCIPAL_INVESTIGATOR)

Find similar trials in Las Vegas, NV

By research site
Las Vegas Clinical Research Unit, PPD Development, LP· Las Vegas, NV

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