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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224793
• Other study ID #: 230HV101
• Status: Completed
• Phase: Phase 1
• Start date: October 4, 2017
• Est. completion date: June 12, 2018

Study information

• Verified date: August 2018
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 12, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• BIIB059
Administered as specified in the treatment arm
• Placebo
Administered as specified in the treatment arm

Locations

Country	Name	City	State
United States	West Coast Clinical Trials	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of Participants With Clinically Significant Abnormal Clinical Laboratory Parameters, Vital Signs, 12-Lead Electrocardiograms (ECG), and Physical Examination Findings		Up to 20 weeks
Primary	Percentage of Participants With Anti-BIIB059 Antibodies		Up to 20 weeks
Secondary	Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28d)		Up to 28 days
Secondary	Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)		Up to 112 days
Secondary	Maximum Observed Concentration (Cmax)		Up to 112 days
Secondary	Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf),		Up to 112 days
Secondary	Time to Reach Maximum Observed Concentration (Tmax)		Up to 112 days
Secondary	Terminal Half-Life (t1/2)		Up to 112 days
Secondary	Time of Last Measurable Concentration (Tlast)		Up to 112 days
Secondary	Apparent Total Clearance (CL/F)		Up to 112 days
Secondary	Apparent Volume of Distribution (Vz/F)		Up to 112 days