RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-08-29

Study Completion:2026-08-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07133828

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

US Biogen Clinical Trial Center

CONTACT

866-633-4636

clinicaltrials@biogen.com

Global Biogen Clinical Trial Center

CONTACT

clinicaltrials@biogen.com

Study Locations (Sites)

PPD Development, LP

Las Vegas, Nevada, 89113

United States

Collaborators and Investigators

Sponsor: Biogen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-29

Study Completion Date2026-08-06

Study Record Updates

Study Start Date2025-08-29

Study Completion Date2026-08-06

Terms related to this study

Additional Relevant MeSH Terms

Healthy Volunteer