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

NCT04593121 | Completed Phase 1 FDA Drug

• 1 other identifier: 271HV101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

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

  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.

  Day -1 up to Day 84

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

  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.

  Day -1 up to Day 169

Secondary Outcomes (18)

• Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf): SAD

  Day 1 pre-dose and multiple time-points up to Day 84

• Maximum Observed Concentration (Cmax): SAD

  Day 1 pre-dose and multiple time-points up to Day 84

• Time to Reach Maximum Observed Concentration (Tmax): SAD

  Day 1 pre-dose and multiple time-points up to Day 84

• Terminal Half-Life (t1/2): SAD

  Day 1 pre-dose and multiple time-points up to Day 84

• Clearance (CL) for IV Doses: SAD

  Day 1 pre-dose and multiple time-points up to Day 84

Study Arms (9)

Cohort 1A

EXPERIMENTAL

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

Drug: BIIB107; Drug: Placebo

Cohort 2A

EXPERIMENTAL

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

Drug: BIIB107; Drug: Placebo

Cohort 3A

EXPERIMENTAL

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

Drug: BIIB107; Drug: Placebo

Cohort 4A

EXPERIMENTAL

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

Drug: BIIB107; Drug: Placebo

Cohort 7A

EXPERIMENTAL

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

Drug: BIIB107; Drug: Placebo

Cohort 5A

EXPERIMENTAL

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

Drug: BIIB107; Drug: Placebo

Cohort 8A

EXPERIMENTAL

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

Drug: BIIB107; Drug: Placebo

Cohort 1B

EXPERIMENTAL

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

Drug: BIIB107; Drug: Placebo

Cohort 2B

EXPERIMENTAL

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

Drug: BIIB107; Drug: Placebo

Interventions

BIIB107 DRUG

Administered as specified in the treatment arm.

Cohort 1A; Cohort 1B; Cohort 2A; Cohort 2B; Cohort 3A; Cohort 4A; Cohort 5A; Cohort 7A; Cohort 8A

Placebo DRUG

Administered as specified in the treatment arm.

Cohort 1A; Cohort 1B; Cohort 2A; Cohort 2B; Cohort 3A; Cohort 4A; Cohort 5A; Cohort 7A; Cohort 8A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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) and participants with immunity to hepatitis B from previous natural infection (defined as negative hepatitis B surface antigen \[HBsAg\], positive hepatitis B surface antibody \[HBsAb\], and positive total hepatitis B core antibody \[HBcAb\]).
• 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)
• History of severe allergic or anaphylactic reactions or history of allergic reactions that, in the opinion of the Investigator, is likely to be exacerbated by any component of the study treatment.
• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (3)

CenExel Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

QPS MRA (Miami Research Associates)

Miami, Florida, 33143, United States

Location

Altasciences Clinical Research

Overland Park, Kansas, 66212, United States

Location

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: October 30, 2020
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)