Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01407406
• Date of registration: 14/07/2011
• Primary sponsor: Biogen Idec
• Public title: Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy Volunteers
• Scientific title: A Single-Dose, Randomized, Double-Blind, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
• Date of first enrolment: September 2011
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01407406
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Countries of recruitment

Australia, China

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: BIIB023 - high dose IV Dose

Drug: BIIB023 - low dose IV Dose

Primary Outcome(s)

AUC of BIIB023 [Time Frame: Participants will be followed for the duration of a study; an expected 71 days]

Clearance of BIIB023 [Time Frame: Participants will be followed for the duration of a study; an expected 71 days]

Cmax of BIIB023 [Time Frame: Participants will be followed for the duration of a study; an expected 71 days]

Half-life of BIIB023 [Time Frame: Participants will be followed for the duration of a study; an expected 71 days]

Tmax of BIIIB023 [Time Frame: Participants will be followed for the duration of a study; an expected 71 days]

Volume of distribution of BIIB023 [Time Frame: Participants will be followed for the duration of a study; an expected 71 days]

Secondary Outcome(s)

Number of patients with Adverse Events as a measure of safety and tolerability [Time Frame: Participants will be followed for the duration of a study; an expected 71 days]

Number of patients with Serious Adverse Events as a measure of safety and tolerability [Time Frame: Participants will be followed for the duration of a study; an expected 71 days]

Secondary ID(s)

211HV102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors