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

NCT03224793 | Completed Phase 1 FDA Drug

• 1 other identifier: 230HV101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (4)

BIIB059 20 mg

EXPERIMENTAL

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

Drug: BIIB059; Drug: Placebo

BIIB059 50mg

EXPERIMENTAL

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

Drug: BIIB059; Drug: Placebo

BIIB059 150mg

EXPERIMENTAL

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

Drug: BIIB059; Drug: Placebo

BIIB059 450mg

EXPERIMENTAL

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

Drug: BIIB059; Drug: Placebo

Interventions

BIIB059 DRUG

Administered as specified in the treatment arm

BIIB059 150mg; BIIB059 20 mg; BIIB059 450mg; BIIB059 50mg

Placebo DRUG

Administered as specified in the treatment arm

BIIB059 150mg; BIIB059 20 mg; BIIB059 450mg; BIIB059 50mg

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

West Coast Clinical Trials

Cypress, California, 90630, United States

Location

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: October 4, 2017
• Primary Completion: June 12, 2018
• Study Completion: June 12, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

US (1)