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OpenTrials
Completed

NCT Number: NCT03224793

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

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

Completed

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West Coast Clinical Trials

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIIB059

Drug

Administered as specified in the treatment arm

Placebo

Drug

Administered as specified in the treatment arm

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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