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

A Blinded, Safety, Tolerability, and Pharmacokinetic Study of Single Doses of BIIB059 in Healthy Japanese Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Placebo; Drug: BIIB059

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • West Coast Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIIB059 20 mg; Participants will receive single subcutaneous (SC) dose of 20 milligram (mg) BIIB059 or matching placebo on Day 1.	Drug: Placebo; Administered as specified in the treatment arm; Drug: BIIB059; Administered as specified in the treatment arm
Experimental: BIIB059 50mg; Participants will receive single SC dose of 50 mg BIIB059 or matching placebo on Day 1.	Drug: Placebo; Administered as specified in the treatment arm; Drug: BIIB059; Administered as specified in the treatment arm
Experimental: BIIB059 150mg; Participants will receive single SC dose of 150 mg BIIB059 or matching placebo on Day 1.	Drug: Placebo; Administered as specified in the treatment arm; Drug: BIIB059; Administered as specified in the treatment arm
Experimental: BIIB059 450mg; Participants will receive single SC dose of 450 mg BIIB059 or matching placebo on Day 1.	Drug: Placebo; Administered as specified in the treatment arm; Drug: BIIB059; Administered as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a participant 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, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose: results in death; life-threatening event; requires inpatient hospitalization; significant disability; congenital anomaly; medically important event.	Up to 20 weeks
Percentage of Participants With Clinically Significant Abnormal Clinical Laboratory Parameters, Vital Signs, 12-Lead Electrocardiograms (ECG), and Physical Examination Findings		Up to 20 weeks
Percentage of Participants With Anti-BIIB059 Antibodies		Up to 20 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28d)	Up to 28 days
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)	Up to 112 days
Maximum Observed Concentration (Cmax)	Up to 112 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf),	Up to 112 days
Time to Reach Maximum Observed Concentration (Tmax)	Up to 112 days
Terminal Half-Life (t1/2)	Up to 112 days
Time of Last Measurable Concentration (Tlast)	Up to 112 days
Apparent Total Clearance (CL/F)	Up to 112 days
Apparent Volume of Distribution (Vz/F)	Up to 112 days

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2017
• Primary Completion (Actual): June 12, 2018
• Study Completion (Actual): June 12, 2018

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 230HV101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No