BIIB142 for Healthy Adults

Overseen By Global Biogen Clinical Trial Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Biogen

Must not be taking: Prescription medications

Disqualifiers: Cardiac, Endocrine, Neurologic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new drug called BIIB142, an experimental treatment, to determine its safety and how the body processes it. Researchers seek to identify any health problems that may occur while taking the drug and establish the highest safe dose. Participants will take the drug either once or daily for 14 days, with some receiving a placebo (a pill with no medicine) instead. Participants should be healthy, weigh at least 50 kilograms, and have no significant medical issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription medications, over-the-counter medications that affect liver or kidney function, or nutraceuticals at least 28 days before the study starts.

Is there any evidence suggesting that BIIB142 is likely to be safe for humans?

Research shows that BIIB142 is undergoing its first human testing. With no previous human studies, the researchers are still learning about its safety. This trial phase aims to assess how well participants tolerate BIIB142 and identify any potential side effects.

As an early-stage study, data on health problems or serious issues linked to the drug are not yet available. The study will begin with small doses, gradually increasing them to determine the highest dose that remains safe.

In summary, safety information for BIIB142 in humans is not yet available, as this study is the first to examine its effects. Participants will be closely monitored to gather information on any reactions. ^{1 2 3 4 5}

Why are researchers excited about this study treatment?

Researchers are excited about BIIB142 because it represents a new approach in the treatment landscape. Unlike other treatments that may focus on managing symptoms, BIIB142 acts by targeting specific biological pathways potentially linked to the root cause of the condition. This novel mechanism of action could offer a more direct and effective intervention. Additionally, the study involves both single and multiple ascending doses, which might help identify the optimal dosage for maximizing benefits and minimizing side effects. This innovative approach could pave the way for more personalized and efficient treatments in the future.

What evidence suggests that BIIB142 could be effective?

The trial is studying BIIB142 as a potential treatment for autoimmune diseases, such as lupus. BIIB142 targets and breaks down a protein called IRAK4, which plays a role in the body's immune response. This action might help reduce the inflammation often seen in these conditions. While no human studies have yet provided data on its effectiveness, early lab research has shown promise. The trial will focus on ensuring the safety of BIIB142 and understanding how the body processes it. Participants will receive different doses of BIIB142 or a matching placebo in various treatment arms. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 55 with a BMI between 18 and 32 kg/m^2, weighing at least 50 kg. Participants must test negative for SARS-CoV-2 before randomization and be in good health as determined by the investigator.

Inclusion Criteria

I weigh at least 50 kg.

My BMI is between 18 and 32.

I am in good health according to my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Part A - Single Ascending Dose (SAD)

Participants receive a single dose of BIIB142 or placebo. Participants stay at the research center for 5 days and return for 4 additional visits.

58 days

5 days in-center, 4 follow-up visits

Part B - Multiple Ascending Dose (MAD)

Participants receive BIIB142 or placebo once daily for 14 days. Participants stay at the research center for 16 days and return for 4 additional visits.

58 days

16 days in-center, 4 follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BIIB142

Trial Overview Researchers are testing BIIB142, a new drug, against a placebo (no real medicine) to see how it's processed in the body and its safety. The study has two parts: Part A involves one dose without food or with food for one group; Part B involves daily doses over two weeks.

How Is the Trial Designed?

Group I: Part B [Multiple Ascending Dose (MAD)]: BIIB142 Cohort 1B Experimental Treatment 2 Interventions

Participants will receive Dose A of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state.

Group II: Part B (MAD): BIIB142 Cohort 3B Experimental Treatment 2 Interventions

Participants will receive Dose D of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state.

Group III: Part B (MAD): BIIB142 Cohort 2B Experimental Treatment 2 Interventions

Participants will receive Dose F of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state.

Group IV: Part A [Single Ascending Dose (SAD)]: BIIB142Cohort 1A Experimental Treatment 2 Interventions

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

Group V: Part A (SAD): BIIB142 Cohort 6A Experimental Treatment 1 Intervention

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 VI: Part A (SAD): BIIB142 Cohort 5A Experimental Treatment 2 Interventions

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

Group VII: Part A (SAD): BIIB142 Cohort 4A Experimental Treatment 2 Interventions

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

Group VIII: Part A (SAD): BIIB142 Cohort 3A Experimental Treatment 2 Interventions

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

Group IX: Part A (SAD): BIIB142 Cohort 2A Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07133828

A Study to Learn About the Safety of BIIB142 and How it is ... 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/4f487f9574528a19/nct07133828-biib142-safety-pharmacokinetics-healthy-adults

A Study to Learn About the Safety of BIIB142 and ... - MedPath 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 ...

3. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-7-2025-4f69a

BIIB142 for Healthy Adults This Phase 1 medical study run by Biogen is evaluating whether BIIB142 will have tolerable side effects & efficacy for patients with Healthy Subjects.

4. clinconnect.io clinconnect.io/trials/NCT07133828

A Study to Learn About the Safety of BIIB142 and How it This clinical trial is a first step in learning about a new drug called BIIB142. Researchers want to find out if BIIB142 is safe for healthy adults aged 18 to ...

5. investors.biogen.com investors.biogen.com/static-files/17569182-fae2-4340-9985-cfebbe73db61

Exhibit 99.1 - Q3 2025 Press Release • IRAK4 degrader (BIIB142) for autoimmune disease, including lupus, initiated Phase 1 study in healthy volunteers. • Added a preclinical ...

6. tipranks.com tipranks.com/news/company-announcements/biogens-biib142-study-a-new-chapter-in-drug-safety-evaluation

Biogen's BIIB142 Study: A New Chapter in Drug Safety ... Biogen Inc. is conducting a Phase 1 clinical trial to evaluate the safety and processing of BIIB142 in healthy adults aged 18 to 55.