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

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-29
• Study Completion Date: 2026-08-06

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.

Detailed 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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 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.

Group Type: EXPERIMENTAL

BIIB142

Intervention Type: DRUG

Administered Orally

BIIB142-Matching Placebo

Intervention Type: DRUG

Administered Orally

Part A (SAD): BIIB142 Cohort 2A

Participants will receive Dose B of BIIB142 or a matching placebo on Day 1 in a fasted state.

Group Type: EXPERIMENTAL

BIIB142

Intervention Type: DRUG

Administered Orally

BIIB142-Matching Placebo

Intervention Type: DRUG

Administered Orally

Part A (SAD): BIIB142 Cohort 3A

Participants will receive Dose C of BIIB142 or a matching placebo on Day 1 in a fasted state.

Group Type: EXPERIMENTAL

BIIB142

Intervention Type: DRUG

Administered Orally

BIIB142-Matching Placebo

Intervention Type: DRUG

Administered Orally

Part A (SAD): BIIB142 Cohort 4A

Participants will receive Dose D of BIIB142 or a matching placebo on Day 1 in a fasted state.

Group Type: EXPERIMENTAL

BIIB142

Intervention Type: DRUG

Administered Orally

BIIB142-Matching Placebo

Intervention Type: DRUG

Administered Orally

Part A (SAD): BIIB142 Cohort 5A

Participants will receive Dose E of BIIB142 or a matching placebo on Day 1 in a fasted state.

Group Type: EXPERIMENTAL

BIIB142

Intervention Type: DRUG

Administered Orally

BIIB142-Matching Placebo

Intervention Type: DRUG

Administered Orally

Part 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.

Group Type: EXPERIMENTAL

BIIB142

Intervention Type: DRUG

Administered Orally

Part 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.

Group Type: EXPERIMENTAL

BIIB142

Intervention Type: DRUG

Administered Orally

BIIB142-Matching Placebo

Intervention Type: DRUG

Administered Orally

Part 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.

Group Type: EXPERIMENTAL

BIIB142

Intervention Type: DRUG

Administered Orally

BIIB142-Matching Placebo

Intervention Type: DRUG

Administered Orally

Part 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.

Group Type: EXPERIMENTAL

BIIB142

Intervention Type: DRUG

Administered Orally

BIIB142-Matching Placebo

Intervention Type: DRUG

Administered Orally

Interventions

BIIB142

Administered Orally

Intervention Type: DRUG

BIIB142-Matching Placebo

Administered Orally

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PPD Development, LP

Las Vegas, Nevada, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

US Biogen Clinical Trial Center

Role: CONTACT

clinicaltrials@biogen.com

866-633-4636

Global Biogen Clinical Trial Center

Role: CONTACT

clinicaltrials@biogen.com

Facility Contacts

Role: primary

702-963-1600

Other Identifiers

300HV101

Identifier Type: -

Identifier Source: org_study_id