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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -1 up to day 169
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective. They will test it on healthy adults to see how it affects them.

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.Check my eligibility
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.See study design
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
Select...
My BMI is between 18 and 30, and I weigh at least 55 kg.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
Secondary outcome measures
Absorption Rate Profile of SC Doses: SAD
Accumulation Ratio (R): MAD
Apparent Clearance (CL/F) of SC Doses: MAD
+15 more

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
BIIB107
2020
Completed Phase 1
~90
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
467,352 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,063,402 Total Patients Enrolled

Media Library

BIIB107 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04593121 — Phase 1
Healthy Subjects Research Study Groups: Cohort 1A, Cohort 2A, Cohort 3A, Cohort 4A, Cohort 7A, Cohort 5A, Cohort 8A, Cohort 1B, Cohort 2B
Healthy Subjects Clinical Trial 2023: BIIB107 Highlights & Side Effects. Trial Name: NCT04593121 — Phase 1
BIIB107 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04593121 — Phase 1
Healthy Subjects Patient Testimony for trial: Trial Name: NCT04593121 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned BIIB107 for patient use?

"As this is a Phase 1 study, there is only minimal data attesting to the safety and efficacy of BIIB107; hence, it received a score of 1."

Answered by AI

Are there any slots open for volunteers in this clinical research?

"Indeed, the clinicaltrials.gov database indicates that this research project is currently recruiting participants. It was initially released on October 30th 2020 and updated most recently on October 10th 2022. This study requires 76 volunteers from 2 trial sites."

Answered by AI

Who meets the requirements to participate in this clinical trial?

"The requirements for participating in this trial are healthy subjects (hs) and being between 18-55 years old. Approximately 76 individuals will join the experiment."

Answered by AI

Does the current research protocol limit participant eligibility to individuals aged 20 or older?

"This clinical trial seeks participants aged 18 to 55. For those younger than 18, fifty trials offer participation opportunities, whereas 373 studies are available for individuals over 65."

Answered by AI

To what extent has recruitment been successful for this experiment?

"Affirmative. The details posted on clinicaltrials.gov demonstrate that this medical investigation, which was originally announced on October 30th 2020, is currently accepting applicants. Approximately 76 candidates need to be sourced from two separate health centres."

Answered by AI

Who else is applying?

What site did they apply to?
CenExel Anaheim Clinical Trials
QPS MRA (Miami Research Associates)
Other
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
What state do they live in?
Other
Kansas
Missouri
California

What questions have other patients asked about this trial?

How much will I make? How long will the trial last? Is it paid? Are there any inpatient stay? Compensation?
PatientReceived 1 prior treatment
Is there Compensation for the pre screening if so how much ? How much is it per meeting and how much is it pre screening?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

My niece has MS. To give back to the people.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Research Site: < 24 hours
  2. CenExel Anaheim Clinical Trials: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants
2020. "Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04593121.
~19 spots leftby Apr 2025
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