NCT07133828 A Study to Learn About the Safety of BIIB142 and How it is Processed in the Body of Healthy Adult Participants Aged 18 to 55 Years Old
| NCT ID | NCT07133828 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Biogen |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-08-29 |
| Primary Completion | 2026-08-06 |
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 78 participants in total. It began in 2025-08-29 with a primary completion date of 2026-08-06.
⚠ 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 more about the safety of BIIB142 and how it is processed in the body. This is the first time that researchers will learn about BIIB142 and how it affects people. 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 a drug during the study. An AE is considered serious when it results in death, is life-threatening, causes lasting problems, or requires hospital care. Researchers will also learn more about: • How the body processes BIIB142 This is a "dose escalation study." This is a study in which increasing amounts of the study drug are given to different groups of participants. This is done until researchers find the highest dose that does not cause harmful effects. First, participants will be screened to check if they can join the study. The screening period will be up to 28 days. This study will be split into 2 parts - Part A and Part B. During Part A: * Participants will be randomly placed into 1 of 6 groups to receive a single dose of either BIIB142 or a placebo. A placebo looks like the study drug but contains no real medicine. * Participants in Groups 1 through 5 will take either BIIB142 or the placebo without food. Participants in Group 6 will take 2 doses of their assigned treatment - once with food and once without food. * Neither the researchers nor the participants will know if the participants will receive BIIB142 or the placebo. * Participants will stay at their study research center for 5 days. They will return for another 4 visits. Each participant in Part A will be in the study for up to 58 days. During Part B: * Participants will be randomly placed into 1 of 3 groups to receive BIIB142 or the placebo. In Part B, participants will take BIIB142 or the placebo once a day for 14 days. * Neither the researchers nor the participants will know if the participants will receive BIIB142 or the placebo. * Participants will stay at their study research center for 16 days. They will return for another 4 visits. Each participant in Part B will be in the study for up to 58 days.
Eligibility Criteria
Key Inclusion Criteria: * Have a body mass index between 18 and 32 kilograms per square meter (kg/m\^2), inclusive, at screening. * Weight ≥ 50 kilograms (kg) at screening. * Negative polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in prior to randomization. * Must be in good health as determined by the Investigator. 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 * History of or ongoing malignant disease (with limited exceptions) * Systolic blood pressure \>150 millimeters of mercury (mmHg) or \<90 mmHg. * Clinically significant (as determined by the Investigator) electrocardiogram (ECG) abnormalities. * History of or positive test for human immunodeficiency virus (HIV). * Chronic, recurrent, or serious infection within 90 days prior to Screening. * Symptoms of bacterial, fungal, or viral infection within 14 days prior to Screening. * Any live or attenuated immunization within 14 days prior to Screening. * Use of prescription medications, over-the-counter medications that alter hepatic or renal clearance, or nutraceuticals within 28 days prior to Check-in. * MAD Cohorts only: Suicidal ideation with some intent to act within 6 months prior to the start of Screening or history of suicidal behavior within one year prior to Screening. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Biogen
Frequently Asked Questions
Who can join the NCT07133828 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 NCT07133828 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 NCT07133828 currently recruiting?
Yes, NCT07133828 is actively recruiting participants. Contact the research team at clinicaltrials@biogen.com for enrollment information.
Where is the NCT07133828 trial being conducted?
This trial is being conducted at Las Vegas, United States.
Who is sponsoring the NCT07133828 clinical trial?
NCT07133828 is sponsored by Biogen. The principal investigator is Medical Director at Biogen. The trial plans to enroll 78 participants.