This study is a randomized, double-blind, dose-escalating phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of 9MW1911 injection in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Experimental drug administered with IV infusion
Placebo administered with IV infusion
Peking Union Hospital
Beijing, Beijing Municipality, China
Adverse Event(including serious adverse event)
Evaluate the safety and tolerability of 9MW1911 in healthy subjects, and to determine the possible maximum tolerated dose (MTD).
Time frame: Day0-Day113
Pharmacokinetics parameters
Maximum concentration(Cmax)
Time frame: Day0-Day113
Pharmacokinetics parameters
The area under the curve (AUC)
Time frame: Day0-Day113
Pharmacokinetics parameters
Time at which maximum concentration(Tmax)
Time frame: Day0-Day113
Pharmacokinetics parameters
The half life(T1/2)
Time frame: Day0-Day113
Immunogenicity parameters
The incidence of ADAs against 9MW1911 during the study will be summarized
Time frame: Day0-Day113
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