This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.
The study included screening period, administration and safety follow-up period. Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
A humanized monoclonal antibody.
PKUCare Luzhong Hospital
Zibo, China
Incidence of Adverse Events (AEs).
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time frame: Up to Week 12.
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