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Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04593121
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
The primary objective is to determine the safety and tolerability of single and multiple ascending subcutaneous (SC) doses and a single intravenous (IV) dose of BIIB107 in healthy adult participants. The secondary objectives are to characterize the single-dose pharmacokinetic (PK) of SC and IV BIIB107 in healthy adult participants and to characterize the multiple-dose PK of SC BIIB107 in healthy adult participants.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: BIIB107 Drug: Placebo Phase 1

Detailed Description:
BIIB107 is a monoclonal antibody (mAb) that targets alpha-4 integrins and is currently in development for people with multiple sclerosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB107 in Healthy Adult Participants
Actual Study Start Date : October 30, 2020
Estimated Primary Completion Date : October 11, 2023
Estimated Study Completion Date : October 11, 2023

Arm Intervention/treatment
Experimental: Cohort 1A
Participants will receive Dose 1 of BIIB107 or placebo subcutaneous (SC) on Day 1.
Drug: BIIB107
Administered as specified in the treatment arm.

Drug: Placebo
Administered as specified in the treatment arm.

Experimental: Cohort 2A
Participants will receive Dose 2 of BIIB107 or placebo SC on Day 1.
Drug: BIIB107
Administered as specified in the treatment arm.

Drug: Placebo
Administered as specified in the treatment arm.

Experimental: Cohort 3A
Participants will receive Dose 3 of BIIB107 or placebo SC on Day 1.
Drug: BIIB107
Administered as specified in the treatment arm.

Drug: Placebo
Administered as specified in the treatment arm.

Experimental: Cohort 4A
Participants will receive Dose 4 of BIIB107 or placebo SC on Day 1.
Drug: BIIB107
Administered as specified in the treatment arm.

Drug: Placebo
Administered as specified in the treatment arm.

Experimental: Cohort 5A
Participants will receive Dose 5 of BIIB107 or placebo intravenous (IV) on Day 1.
Drug: BIIB107
Administered as specified in the treatment arm.

Drug: Placebo
Administered as specified in the treatment arm.

Experimental: Cohort 7A
Participants will receive Dose 5 of BIIB107 or placebo SC on Day 1.
Drug: BIIB107
Administered as specified in the treatment arm.

Drug: Placebo
Administered as specified in the treatment arm.

Experimental: Cohort 8A
Participants will receive Dose 6 of BIIB107 or placebo SC on Day 1.
Drug: BIIB107
Administered as specified in the treatment arm.

Drug: Placebo
Administered as specified in the treatment arm.

Experimental: Cohort 1B
Participants will receive multiple doses of BIIB107 or placebo SC on approximately 4 dosing days.
Drug: BIIB107
Administered as specified in the treatment arm.

Drug: Placebo
Administered as specified in the treatment arm.

Experimental: Cohort 2B
Participants will receive multiple doses of BIIB107 or placebo SC on approximately 4 dosing days.
Drug: BIIB107
Administered as specified in the treatment arm.

Drug: Placebo
Administered as specified in the treatment arm.




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Single Ascending Dose (SAD) [ Time Frame: Day -1 up to Day 84 ]
    An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.

  2. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Multiple Ascending Dose (MAD) [ Time Frame: Day -1 up to Day 169 ]
    An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.


Secondary Outcome Measures :
  1. Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf): SAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 84 ]
  2. Maximum Observed Concentration (Cmax): SAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 84 ]
  3. Time to Reach Maximum Observed Concentration (Tmax): SAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 84 ]
  4. Terminal Half-Life (t1/2): SAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 84 ]
  5. Clearance (CL) for IV Doses: SAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 84 ]
  6. Apparent Clearance (CL/F) of SC Doses: SAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 84 ]
  7. Volume of Distribution at Steady State (Vss) for IV Doses: SAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 84 ]
  8. Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for SC Doses: SAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 84 ]
  9. Bioavailability (F) of SC Doses: SAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 84 ]
  10. Absorption Rate Profile of SC Doses: SAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 84 ]
  11. Maximum Observed Concentration (Cmax): MAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 169 ]
  12. Time to Reach Maximum Observed Concentration (Tmax): MAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 169 ]
  13. Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau): MAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 169 ]
  14. Trough Concentration (Ctrough): MAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 169 ]
  15. Terminal Half-Life (t1/2): MAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 169 ]
  16. Accumulation Ratio (R): MAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 169 ]
  17. Apparent Clearance (CL/F) of SC Doses: MAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 169 ]
  18. Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for SC Doses: MAD [ Time Frame: Day 1 pre-dose and multiple time-points up to Day 169 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • 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)
  • All women of childbearing potential must practice highly effective contraception during the study and for a period of 90 days, which is expected to be more than 5 half-lives of BIIB107. 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 treatment. In addition, participants should not donate sperm or eggs during the study and for at least 5 half-lives of BIIB107 or 90 days after their last dose of study treatment
  • Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction test at Screening and Check-in/admission.

Key Exclusion Criteria:

  • History of or positive test result at Screening for human immunodeficiency virus (HIV-1/HIV-2) antibodies
  • Positive test result at Screening for hepatitis C virus (HCV) antibody (Ab).
  • Current hepatitis B infection (defined as per protocol).
  • Signs of active herpes simplex type 1 and 2 or varicella within 4 weeks prior to randomization
  • Evidence of current SARS-CoV-2 infection within 4 weeks prior to Screening, at Screening, between Screening and inpatient admission (Day -1), or at admission (Day -1), including but not limited to a fever (temperature >37.5°C), new and persistent cough, breathlessness, or loss of taste or smell, per the judgement of the Investigator.
  • Close contact with an individual with coronavirus disease 2019 (COVID-19) infection within 14 days prior to admission (Day -1). Close contact is defined as being within 6 feet of an infected person as confirmed via laboratory assessment for at least 15 minutes within 2 days of symptom onset (or within 2 days of specimen collection for COVID-19 testing for close contact with asymptomatic person).
  • 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])
  • John Cunningham virus (JCV) seropositivity at Screening (for potential participants enrolling in Part B)
  • Ongoing or past malignancy, carcinoma in situ, or high-grade dysplasia (with the exception of no more than 1 basal cell carcinoma or squamous cell carcinoma that was completely excised and cured at least 12 months prior to randomization)
  • Any prior exposure to mAbs, Fc-fusion proteins, or the following immunomodulator therapies per investigator judgement: natalizumab or any other anti-α4 integrin antibodies, anti-CD20, sphingosine-1-phosphate receptor modulators, or fumarate therapies.
  • Any previous exposure to immunosuppressants (in particular mitoxantrone, methotrexate, azathioprine, cyclophosphamide, and mycophenolate mofetil). Any corticosteroid use should be discussed with the Sponsor prior to enrollment
  • Part B only: Women of childbearing potential.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593121


Contacts
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Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
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United States, California
Research Site Recruiting
Anaheim, California, United States, 92801
United States, Kansas
Research Site Recruiting
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT04593121    
Other Study ID Numbers: 271HV101
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No