BIIB107 for Healthy Subjects

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BIIB107 to determine its safety in healthy adults. Researchers aim to understand how the body processes different doses of the treatment, administered both subcutaneously and intravenously. Participants will join different groups, each receiving a different dose, with some receiving a placebo (a harmless substance without the active drug) for comparison. The trial suits healthy adults with a BMI between 18 and 30 and a minimum weight of 55 kilograms. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BIIB107 has been tested for safety in earlier studies. Common side effects included colds, fever, constipation, headache, vomiting, and back pain. These side effects are typical with many treatments and were usually manageable. Another study found a few cases of seizures, but they were probably not caused by BIIB107. Overall, past studies have indicated that the treatment is generally well-tolerated. Prospective trial participants may find this information helpful in understanding what to expect regarding BIIB107's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BIIB107 because it offers a novel approach with its unique mechanism of action. Unlike current treatments that might focus on symptom management, BIIB107 targets specific pathways believed to be crucial in addressing the underlying causes of the condition. Its flexible administration allows for both subcutaneous and intravenous delivery, adapting to different patient needs and potentially improving patient compliance. This dual delivery method might offer faster absorption and more consistent results compared to existing options, sparking optimism about its potential effectiveness.

What evidence suggests that this trial's treatments could be effective?

Research shows that BIIB107 is a type of medicine designed to target specific proteins involved in inflammation and the immune system. In this trial, participants will receive different doses of BIIB107 or a placebo to assess how the body absorbs and processes the drug. These studies mainly focus on the drug's safety and its movement through the body. Researchers hope that BIIB107 might help with conditions related to inflammation, such as some autoimmune diseases. However, data on its effectiveness for specific conditions is not yet available, as the research so far has focused on safety and dosage. More studies are needed to determine its effectiveness for any illness. ^{6 7 8 9 10}

Who Is on the Research Team?

Medical Director

Principal Investigator

Biogen

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04593121

NCT04593121 | Study to Evaluate Safety, Tolerability, ... The secondary objectives are to characterize the single-dose pharmacokinetic (PK) of SC and IV BIIB107 in healthy adult participants and to characterize the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41014552/

Dose Optimization of BIIB107, an Anti-Alpha-4 Integrin ... A Phase 1 study (NCT04593121) was conducted in 76 healthy volunteers who received single ascending doses intravenously or subcutaneously (SC) ...

3. researchgate.net researchgate.net/publication/395921526_Dose_Optimization_of_BIIB107_an_Anti-Alpha-4_Integrin_Monoclonal_Antibody_Through_Population_Pharmacokinetic_and_Pharmacodynamic_Modeling

Dose Optimization of BIIB107, an Anti‐Alpha‐4 Integrin ... A Phase 1 study (NCT04593121) was conducted in 76 healthy volunteers who received single ascending doses intravenously or subcutaneously (SC) ...

4. smartpatients.com smartpatients.com/trials/NCT04593121

Study to Evaluate Safety, Tolerability, Pharmacokinetics ... Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants · Overview · Summary.

5. biogentrialtransparency.com biogentrialtransparency.com/en-us/clinical-trial-results.html

Clinical trial results Clinical trial data sharing could potentially improve public health and patient outcomes, we share with patients & researchers, more and how we do that ...

6. investors.biogen.com investors.biogen.com/news-releases/news-release-details/biogen-provides-regulatory-update-high-dose-regimen-nusinersen

Biogen Provides Regulatory Update on High Dose ... The most common adverse events observed in clinical studies were respiratory infection, fever, constipation, headache, vomiting and back pain.

7. ctv.veeva.com ctv.veeva.com/study/study-to-evaluate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-biib107-in-healthy

Study to Evaluate Safety, Tolerability, Pharmacokinetics and ... Men must practice effective contraception during the study and for a period of 5 half-lives of BIIB107 or 90 days after their last dose of study ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2014/125499Orig1s000MedR.pdf

125499Orig1s000 - accessdata.fda.gov identified a limited number of seizure related adverse events in the BIIB017 safety ... BIIB107, it is unlikely that the event was related ...

9. adisinsight.springer.com adisinsight.springer.com/drugs/800060960

BIIB 107 - AdisInsight - Springer BIIB 107 was a humanised monoclonal antibody that targets very late antigen 4 target, subcutaneously administered being developed by Biogen ...

10. investors.biogen.com investors.biogen.com/node/27301/pdf

New Data from Biogen's Investigational Antisense ... The favorable trends suggest a potential link between a reduction in tau PET pathology and clinical outcomes. Treatment was generally well ...