Status:
COMPLETED
Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy Volunteers
Lead Sponsor:
Biogen
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese populations to support future clinical development of BIIB023 in China and Japan. Study Design: This is a ...
Detailed Description
Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese populations to support future clinical development of BIIB023 in China and Japan. Study Design: This is a ...
Eligibility Criteria
Inclusion
- Must have the ability to understand the purpose and risks of the study \& provide signed \& dated informed consent.
- Chinese, Japanese or Caucasian subjects
- Subjects of childbearing potential must practice effective contraception during the study and 3 months after their last dose of study treatment.
- Must have a BMI within the range of 18.5 to 25 kg/m2.
- Must be willing to abstain from using tobacco and tobacco-containing products during the in-clinic period.
- Must be willing to limit alcohol intake to no more than 2 units per day throughout the duration of the study (with some stricter exceptions at various timepoints).
- Must be deemed healthy as determined by the Investigator, based on assessments at Screening and Day -1.
Exclusion
- Known to have a positive test result for Human Immunodeficiency Virus (HIV) antibody.
- Known history of hepatitis C or hepatitis B virus.
- History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test.
- Subjects with a history of carcinoma in situ and malignant disease. (with the exception of basal cell carcinoma that has been completely excised prior to study)
- History of clinically important severe allergic or anaphylactic reactions.
- Known allergy to components of the BIIB023 formulation.
- History of any clinically important cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
- Abnormal hematology or blood chemistry values at Screening or Day -1, as determined by the Investigator.
- Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Screening.
- History of drug or alcohol abuse (as defined by the Investigator) within 6 months prior to screening, and/or a positive urine drug screen (without a medically indicated rationale) or positive alcohol breath test at Screening or on Day -1.
- Active bacterial or viral infection and fever \>38°C within 48 hours prior to study treatment administration.
- Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
- Surgery within 3 months prior to Day -1 or any surgical procedure planned during the course of the study
- Previous exposure to BIIB023.
- Treatment with another investigational drug , device, or approved therapy for investigational use within 30 days prior to Day -1, or 7 half lives of the investigational product, whichever is longer
- Treatment with any prescription medication within 2 weeks before Day -1 with the exception of oral contraceptives for women of childbearing potential.
- Treatment with any nonprescription medicinal products (including vitamin/mineral/herbal containing preparations but excluding acetaminophen) within the 7 days prior to study treatment.
- Vaccination within 4 weeks of study treatment.
- Blood donation (1 unit or more) within 1 month prior to study treatment or plasma donation within 7 days prior to study treatment.
- Alcohol use within 48 hours prior to study treatment or during the In-Clinic period.
- Current enrollment in any other study treatment or disease study.
- Inability to comply with study requirements.
- Vigorous exercise (as determined by the Investigator) within 72 hours prior to any study visit.
- Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01407406
Start Date
September 1 2011
End Date
February 1 2012
Last Update
September 16 2013
Active Locations (2)
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1
Research Site
Melbourne, Victoria, Australia
2
Research Site
Hong Kong, Hong Kong, China