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Safety, Tolerability, and Pharmacokinetics of Single Doses of BIIB059 in Healthy Japanese Subjects.

NCT ID: NCT03224793

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-04

Study Completion Date

2018-06-12

Brief Summary

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To assess the safety and tolerability of single, subcutaneous (SC) doses of BIIB059 in healthy Japanese subjects.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BIIB059 20 mg

Participants will receive single subcutaneous (SC) dose of 20 milligram (mg) BIIB059 or matching placebo on Day 1.

Group Type EXPERIMENTAL

BIIB059

Intervention Type DRUG

Administered as specified in the treatment arm

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm

BIIB059 50mg

Participants will receive single SC dose of 50 mg BIIB059 or matching placebo on Day 1.

Group Type EXPERIMENTAL

BIIB059

Intervention Type DRUG

Administered as specified in the treatment arm

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm

BIIB059 150mg

Participants will receive single SC dose of 150 mg BIIB059 or matching placebo on Day 1.

Group Type EXPERIMENTAL

BIIB059

Intervention Type DRUG

Administered as specified in the treatment arm

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm

BIIB059 450mg

Participants will receive single SC dose of 450 mg BIIB059 or matching placebo on Day 1.

Group Type EXPERIMENTAL

BIIB059

Intervention Type DRUG

Administered as specified in the treatment arm

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm

Interventions

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BIIB059

Administered as specified in the treatment arm

Intervention Type DRUG

Placebo

Administered as specified in the treatment arm

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations
* Must have been born in Japan, and both their biological parents and grandparents must have been of Japanese origin
* Aged 18 to 55 years old, inclusive, at the time of informed consent, and must have a body mass index between 18 and 30 kilogram per square meter (kg/m2), and a body weight \>45 kg
* All women of childbearing potential and all men must practice highly effective contraception during the study and for 16 weeks after their dose of study treatment

Exclusion Criteria

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator
* History or positive test result for human immunodeficiency virus. Current active hepatitis C virus infection (defined as hepatitis C virus RNA above the limit of detection). Positive test result for hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody). Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1
* Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day -1
* Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 5 half-lives prior to Day -1
* History of alcohol or substance abuse (as determined by the Investigator), a positive urine drug or alcohol test at Screening or Day -1, an unwillingness to refrain from illicit or recreational drugs, or an unwillingness to abide by the alcohol restrictions
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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West Coast Clinical Trials

Cypress, California, United States

Site Status

Countries

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United States

Other Identifiers

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230HV101

Identifier Type: -

Identifier Source: org_study_id

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