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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: BIIB059

Study type: Interventional

Funder types: Industry

Identifiers

NCT03224793

230HV101

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

32 participants in 4 patient groups

BIIB059 20 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BIIB059

BIIB059 50mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BIIB059

BIIB059 150mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BIIB059

BIIB059 450mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BIIB059