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NCT07225517 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult Participants
A Phase 1 study of Healthy Volunteer, sponsored by Biogen.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
- 1
- Study location
NCT07225517: Recruiting Phase 1 study of Healthy Volunteer, sponsored by Biogen.
NCT07225517 is a Phase 1 study of Healthy Volunteer that is actively recruiting participants, run by Biogen. The registered enrollment target is 104 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07225517, a Phase 1 study of Healthy Volunteer, is actively recruiting participants, sponsored by Biogen.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
- 1
- Study location
Study 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 th
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BIIB145
Study Locations (1)
Texas
- PPD Austin Clinic - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2025-12-18 |
| Est. Completion | 2027-02-02 |
| Phase | Phase 1 |
What NCT07225517 shows while recruiting
NCT07225517 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07225517 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT07225517 about?
NCT07225517 is a clinical study titled "A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult Participants". 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 b...
What is the current status of trial NCT07225517?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2025-12-18. Estimated completion is 2027-02-02.
What conditions does trial NCT07225517 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT07225517?
The interventions under investigation include: Placebo (DRUG), BIIB145 (DRUG).
Who is sponsoring clinical trial NCT07225517?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07225517 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07225517's enrollment target sits among peer trials
104 29th of 112 higher than 84 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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