Safety, Tolerability, and Pharmacokinetics of Single Dose... | NCT03224793

NCT03224793

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BIIB059	Drug	Administered as specified in the treatment arm	BIIB059 150mg BIIB059 20 mg BIIB059 450mg BIIB059 50mg

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	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

Eligibility Module

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