BIIB107 for Healthy Subjects

Recruiting at 7 trial locations

Overseen By Martin K Kankam

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Biogen

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: HIV, Hepatitis, Tuberculosis, others

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

Compensation: Varies

Number of Visits: 3

84 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing BIIB107, a lab-made protein, in healthy adults to ensure it is safe and understand how the body processes it. BIIB107 works by attaching to specific cell proteins to block harmful activities.

Do I need to stop taking my current medications for the BIIB107 trial?

The trial information does not specify if you need to stop taking your current medications. However, any previous exposure to certain immunosuppressants and corticosteroid use should be discussed with the Sponsor before enrollment.

Research Team

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

Healthy adults with a BMI of 18-30 kg/m^2 and weight over 55 kg can join. They must not have HIV, hepatitis B or C, recent herpes or varicella, TB exposure, COVID-19 contact within 14 days before the trial, or any malignancy history except certain skin cancers cured over a year ago. Women who can bear children and men must use effective contraception during the study.

Inclusion Criteria

Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction test at Screening and Check-in/admission

My BMI is between 18 and 30, and I weigh at least 55 kg.

I am using or willing to use effective birth control during and after the study.

Exclusion Criteria

I have had symptoms or tested positive for COVID-19 recently.

I have tested positive for the John Cunningham virus.

I have had tuberculosis or tested positive for TB.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Single Ascending Dose (SAD) Treatment

Participants receive a single subcutaneous or intravenous dose of BIIB107 or placebo

12 weeks

Multiple visits (in-person)

Multiple Ascending Dose (MAD) Treatment

Participants receive multiple subcutaneous doses of BIIB107 or placebo over approximately 4 dosing days

24 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• BIIB107
• Placebo

Trial Overview The trial is testing BIIB107's safety when given as a single subcutaneous (SC) dose, multiple SC doses, and one intravenous (IV) dose in healthy people. It also looks at how the body processes this drug after different dosing schedules.

Participant Groups

Group I: Cohort 8A Experimental Treatment 2 Interventions

Participants will receive Dose 6 of BIIB107 or placebo SC on Day 1.

Group II: Cohort 7A Experimental Treatment 2 Interventions

Participants will receive Dose 5 of BIIB107 or placebo SC on Day 1.

Group III: Cohort 5A Experimental Treatment 2 Interventions

Participants will receive Dose 5 of BIIB107 or placebo intravenous (IV) on Day 1.

Group IV: Cohort 4A Experimental Treatment 2 Interventions

Participants will receive Dose 4 of BIIB107 or placebo SC on Day 1.

Group V: Cohort 3A Experimental Treatment 2 Interventions

Participants will receive Dose 3 of BIIB107 or placebo SC on Day 1.

Group VI: Cohort 2B Experimental Treatment 2 Interventions

Participants will receive multiple doses of BIIB107 or placebo SC on approximately 4 dosing days.

Group VII: Cohort 2A Experimental Treatment 2 Interventions

Participants will receive Dose 2 of BIIB107 or placebo SC on Day 1.

Group VIII: Cohort 1B Experimental Treatment 2 Interventions

Participants will receive multiple doses of BIIB107 or placebo SC on approximately 4 dosing days.

Group IX: Cohort 1A Experimental Treatment 2 Interventions

Participants will receive Dose 1 of BIIB107 or placebo subcutaneous (SC) on Day 1.

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