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BiogenA 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 Phase 1 78 Dose Escalation Single Dose
Clinical Trial NCT07133828 is designed to study Treatment for Healthy Volunteer. It is a Phase 1 interventional study that is recruiting, having started on 29 August 2025, with plans to enroll 78 participants. Led by Biogen, it is expected to complete by 6 August 2026. The latest data from ClinicalTrials.gov was last updated on 11 September 2025.
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 dur...
Show MoreDetailed Description
The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB142 in healthy adult participants.
The secondary objective of this study is to evaluate the pharmacokinetics (PK) profile of single and multiple ascending oral doses of BIIB142 in healthy adult participants.
Official Title
A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB142 in Healthy Adults
Conditions
Healthy VolunteerOther Study IDs
- 300HV101
NCT ID Number
Start Date (Actual)
2025-08-29
Last Update Posted
2025-09-11
Completion Date (Estimated)
2026-08-06
Enrollment (Estimated)
78
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPart A [Single Ascending Dose (SAD)]: BIIB142Cohort 1A Participants will receive Dose A of BIIB142 or a matching placebo on Day 1 in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
ExperimentalPart A (SAD): BIIB142 Cohort 2A Participants will receive Dose B of BIIB142 or a matching placebo on Day 1 in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
ExperimentalPart A (SAD): BIIB142 Cohort 3A Participants will receive Dose C of BIIB142 or a matching placebo on Day 1 in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
ExperimentalPart A (SAD): BIIB142 Cohort 4A Participants will receive Dose D of BIIB142 or a matching placebo on Day 1 in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
ExperimentalPart A (SAD): BIIB142 Cohort 5A Participants will receive Dose E of BIIB142 or a matching placebo on Day 1 in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
ExperimentalPart A (SAD): BIIB142 Cohort 6A Participants will receive BIIB142 on Day 1 in the fasted followed by fed state in the first sequence, and vice versa in the second sequence. A washout period of 14 days will be maintained between both the sequences. Dose will be determined based on emerging PK data. | BIIB142 Administered Orally |
ExperimentalPart B [Multiple Ascending Dose (MAD)]: BIIB142 Cohort 1B Participants will receive Dose A of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
ExperimentalPart B (MAD): BIIB142 Cohort 2B Participants will receive Dose F of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
ExperimentalPart B (MAD): BIIB142 Cohort 3B Participants will receive Dose D of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29 | |
Number of Participants with Clinical Laboratory Abnormalities | Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29 | |
Number of Participants with Potentially Clinically Relevant Abnormalities in Vital Sign Parameters | Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29 | |
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score | Part B (MAD): Up to Day 29 | |
Number of Participants With Potentially Clinically Relevant Abnormalities in 12-lead Electrocardiogram (ECG) Parameters | Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Plasma Concentration of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
Area Under the Concentration-Time Curve (AUC) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
Maximum Observed Concentration (Cmax) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
Time to Maximum Observed Concentration (Tmax) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
Apparent Clearance (CL/F) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
Apparent Volume of Distribution (Vz/F) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
Elimination Half-Life (t1/2) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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.
- 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.
BiogenStudy Central Contact
Contact: US Biogen Clinical Trial Center, 866-633-4636, [email protected]
Contact: Global Biogen Clinical Trial Center, [email protected]
1 Study Locations in 1 Countries
Nevada
PPD Development, LP, Las Vegas, Nevada, 89113, United States
Contact, 702-963-1600
Shawn Searle, Principal Investigator
Recruiting