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

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ClinicalTrials.gov Identifier: NCT03224793
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: BIIB059 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Blinded, Safety, Tolerability, and Pharmacokinetic Study of Single Doses of BIIB059 in Healthy Japanese Subjects
Actual Study Start Date : October 4, 2017
Actual Primary Completion Date : June 12, 2018
Actual Study Completion Date : June 12, 2018
Arms and Interventions
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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: BIIB059
Administered as specified in the treatment arm

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

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

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

Drug: Placebo
Administered as specified in the treatment arm


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 20 weeks ]
    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.

  2. Percentage of Participants With Clinically Significant Abnormal Clinical Laboratory Parameters, Vital Signs, 12-Lead Electrocardiograms (ECG), and Physical Examination Findings [ Time Frame: Up to 20 weeks ]
  3. Percentage of Participants With Anti-BIIB059 Antibodies [ Time Frame: Up to 20 weeks ]

Secondary Outcome Measures :
  1. Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28d) [ Time Frame: Up to 28 days ]
  2. Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) [ Time Frame: Up to 112 days ]
  3. Maximum Observed Concentration (Cmax) [ Time Frame: Up to 112 days ]
  4. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf), [ Time Frame: Up to 112 days ]
  5. Time to Reach Maximum Observed Concentration (Tmax) [ Time Frame: Up to 112 days ]
  6. Terminal Half-Life (t1/2) [ Time Frame: Up to 112 days ]
  7. Time of Last Measurable Concentration (Tlast) [ Time Frame: Up to 112 days ]
  8. Apparent Total Clearance (CL/F) [ Time Frame: Up to 112 days ]
  9. Apparent Volume of Distribution (Vz/F) [ Time Frame: Up to 112 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224793


Locations
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United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03224793    
Other Study ID Numbers: 230HV101
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No