Clinical trial NCT03224793: Safety, Tolerability, and Pharmacokinetics of Single Doses of BIIB059 in Healthy Japanese Subjects.
Official title: A Blinded, Safety, Tolerability, and Pharmacokinetic Study of Single Doses of BIIB059 in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 20 weeks
measure: Percentage of Participants With Clinically Significant Abnormal Clinical Laboratory Parameters, Vital Signs, 12-Lead Electrocardiograms (ECG), and Physical Examination Findings
timeFrame: Up to 20 weeks
measure: Percentage of Participants With Anti-BIIB059 Antibodies
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28d)
timeFrame: Up to 28 days
measure: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
timeFrame: Up to 112 days
measure: Maximum Observed Concentration (Cmax)
timeFrame: Up to 112 days
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf),
timeFrame: Up to 112 days
measure: Time to Reach Maximum Observed Concentration (Tmax)
timeFrame: Up to 112 days
measure: Terminal Half-Life (t1/2)
timeFrame: Up to 112 days
measure: Time of Last Measurable Concentration (Tlast)
timeFrame: Up to 112 days
measure: Apparent Total Clearance (CL/F)
timeFrame: Up to 112 days
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: Up to 112 days
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials
state: California
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: