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

NCT01407406 | Completed Phase 1

• 1 other identifier: 211HV102
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 2

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 single-dose study to assess the PK, safety, and tolerability of BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy volunteers. The Caucasian group is included to allow comparison of PK data from different groups using data from the same study under the same controlled conditions. Subjects will be in the clinic for 48 hours around the time of dosing and in the study for up to 100 days.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• AUC of BIIB023

  Participants will be followed for the duration of a study; an expected 71 days

• Cmax of BIIB023

  Participants will be followed for the duration of a study; an expected 71 days

• Tmax of BIIIB023

  Participants will be followed for the duration of a study; an expected 71 days

• Half-life of BIIB023

  Participants will be followed for the duration of a study; an expected 71 days

• Volume of distribution of BIIB023

  Participants will be followed for the duration of a study; an expected 71 days

• Clearance of BIIB023

  Participants will be followed for the duration of a study; an expected 71 days

Secondary Outcomes (2)

• Number of patients with Adverse Events as a measure of safety and tolerability

  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

  Participants will be followed for the duration of a study; an expected 71 days

Study Arms (6)

Chinese Subjects - low dose BIIB023 IV

EXPERIMENTAL

Drug: BIIB023 - low dose IV Dose

Chinese Subjects - high dose BIIB023 IV

EXPERIMENTAL

Drug: BIIB023 - high dose IV Dose

Japanese Subjects - low dose BIIB023 IV

EXPERIMENTAL

Drug: BIIB023 - low dose IV Dose

Japanese Subjects - high dose BIIB023 IV

EXPERIMENTAL

Drug: BIIB023 - high dose IV Dose

Causasian Subjects - low dose BIIB023 IV

EXPERIMENTAL

Drug: BIIB023 - low dose IV Dose

Caucasian Subjects - high dose BIIB023 IV

EXPERIMENTAL

Drug: BIIB023 - high dose IV Dose

Interventions

BIIB023 - low dose IV Dose DRUG

Causasian Subjects - low dose BIIB023 IV; Chinese Subjects - low dose BIIB023 IV; Japanese Subjects - low dose BIIB023 IV

BIIB023 - high dose IV Dose DRUG

Caucasian Subjects - high dose BIIB023 IV; Chinese Subjects - high dose BIIB023 IV; Japanese Subjects - high dose BIIB023 IV

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (2)

Research Site

Melbourne, Victoria, Australia

Location

Research Site

Hong Kong, Hong Kong, China

Location

MeSH Terms

Interventions

BIIB023

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: August 2, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: September 16, 2013

Record last verified: 2012-03

Locations

CN (1); AU (1)