NCT07662148 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
| NCT ID | NCT07662148 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Biogen |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-07-21 |
| Primary Completion | 2028-06-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2026-07-21 with a primary completion date of 2028-06-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Key Inclusion Criteria: * Have a body mass index (BMI) between 18 and 32 kilograms per square metre (kg/m\^2), inclusive, at Screening. * Must be in good health as determined by the Investigator, based on medical history and Screening evaluations. Key Exclusion Criteria: * History of any clinically significant 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 severe allergic or anaphylactic reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment. * History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 1 year prior to Day -1). * History of, or positive test result at Screening for, human immunodeficiency virus (HIV). * Any live or attenuated immunization or vaccination given within 14 days prior to Screening, between Screening and Day -1, or planned to be given during the study period. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Biogen
Frequently Asked Questions
Who can join the NCT07662148 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07662148 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07662148 currently recruiting?
Yes, NCT07662148 is actively recruiting participants. Contact the research team at clinicaltrials@biogen.com for enrollment information.
Where is the NCT07662148 trial being conducted?
This trial is being conducted at Las Vegas, United States.
Who is sponsoring the NCT07662148 clinical trial?
NCT07662148 is sponsored by Biogen. The principal investigator is Medical Director at Biogen. The trial plans to enroll 48 participants.