What side effects are associated with this type of intervention?

Common side effects for treatments administered subcutaneously (SC) or intravenously (IV) in healthy subjects often include local injection site reactions such as erythema, pain, or bruising. These reactions are usually mild. Other potential side effects can include hypersensitivity reactions like rash, pruritus, and urticaria. Serious allergic reactions are rare but have been reported. Neurocognitive symptoms and muscle toxicity are generally uncommon. Overall, these treatments are typically well-tolerated with serious adverse effects being rare.

What prior FDA approvals exist?

The FDA has previously approved various drugs and treatments that have undergone rigorous evaluation for safety, tolerability, and pharmacokinetics in healthy subjects. These studies are essential for understanding the basic pharmacological profile of new drugs before they are tested in patients with specific conditions. For example, drugs like monoclonal antibodies and other biologics often undergo initial trials in healthy volunteers to assess these parameters. While specific drugs similar to BIIB107 are not detailed, the general approach involves single and multiple ascending dose studies to establish a safety and tolerability baseline.

What other types of research exist?

Promising, novel alternatives to BIIB107 for healthy subjects in 2024 include new formulations of 4-1BB agonists and bispecific fusion proteins targeting 4-1BB and PD-L1. These alternatives are being developed to improve efficacy and reduce toxicity, making them suitable candidates for early-phase trials focused on safety, tolerability, and pharmacokinetics.

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BIIB107 for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Biogen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2), inclusive, and must weigh at least 55 kilogram (kg)

Be between 18 and 65 years old

Must not have

John Cunningham virus (JCV) seropositivity at Screening (for potential participants enrolling in Part B)

History of tuberculosis (TB) or positive QuantiFERON® TB Gold test or, if the QuantiFERON TB Gold test is not available, a positive purified protein derivative (PPD/Mantoux test; positive PPD/Mantoux test is defined as ≥5 millimeter (mm) of induration [size of raised lump, not redness])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -1 up to day 169

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed but generally include reactions related to drug infusion or injection site like pain or swelling; potential allergic reactions; and other common symptoms that will be monitored for safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tested positive for the John Cunningham virus.

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I have had tuberculosis or tested positive for TB.

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I have immunity to hepatitis B or a current hepatitis B infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -1 up to day 169

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day -1 up to day 169

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -1 up to day 169 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Multiple Ascending Dose (MAD)

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Single Ascending Dose (SAD)

Trial Design

9Treatment groups

Experimental Treatment

Group I: Cohort 8AExperimental Treatment2 Interventions

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

Group II: Cohort 7AExperimental Treatment2 Interventions

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

Group III: Cohort 5AExperimental Treatment2 Interventions

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

Group IV: Cohort 4AExperimental Treatment2 Interventions

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

Group V: Cohort 3AExperimental Treatment2 Interventions

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

Group VI: Cohort 2BExperimental Treatment2 Interventions

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

Group VII: Cohort 2AExperimental Treatment2 Interventions

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

Group VIII: Cohort 1BExperimental Treatment2 Interventions

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

Group IX: Cohort 1AExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

BIIB107

2020

Completed Phase 1

~90

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments in healthy subjects, such as those studied in the BIIB107 trial, often involve biologics or small molecules administered subcutaneously (SC) or intravenously (IV). These treatments work by targeting specific pathways or receptors to modulate physiological responses. Understanding the pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted) and pharmacodynamics (the drug's effects on the body) is essential. This knowledge ensures that the treatments are safe, well-tolerated, and effective, which is crucial for developing new therapies and ensuring they do not cause adverse effects in healthy individuals.

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