This is a single-center, randomized, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, PK profile, and immunogenicity of multiple SC administraion of CM326 at different doses in healthy subjects. 40 healthy male subjects will be enrolled in the study. The drug will be administered by dose-escalating principle at 4 dose levels: 55 mg Q2W, 110 mg Q2W, 220 mg Q2W, 220 mg Q4W.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
West China Hospital of Sichuan University
Chengdu, Sichuan, 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 24
PK parameters: time to maximum concentration (Tmax).
Time to maximum concentration (Tmax).
Time frame: up to Week 16
PK parameters: maximum concentration (Cmax).
Maximum concentration (Cmax).
Time frame: up to Week 16
PK parameters: area under the plasma concentration-time curve over a dosing interval (AUCtau).
Area under the plasma concentration-time curve over a dosing interval (AUCtau).
Time frame: up to Week 16
PK parameters: area under the plasma concentration-time curve from 0 to t (AUC0-t).
Area under the plasma concentration-time curve from 0 to t (AUC0-t).
Time frame: up to Week 16
Immunogenicity endpoints: Occurrence of anti-drug antibodies (ADA) to CM326.
Occurrence of anti-drug antibodies (ADA) to CM326.
Time frame: up to Week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.