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.
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, Randomized, Double-Blind, parallel-group study to evaluate 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
48
Research Site
Melbourne, Victoria, Australia
Research Site
Hong Kong, Hong Kong, China
AUC 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
Tmax of BIIIB023
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
Volume of distribution 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
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
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