West China Hospital of Sichuan University
Chengdu, Sichuan, China
NCT Number: NCT05171348
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.
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Notify Me18 year–65 year
Male
Interventional
Phase 1
Chengdu, Sichuan, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a humanized monoclonal antibody
Placebo
Time frame: up to Week 24
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time frame: up to Week 16
Time to maximum concentration (Tmax).
Time frame: up to Week 16
Maximum concentration (Cmax).
Time frame: up to Week 16
Area under the plasma concentration-time curve over a dosing interval (AUCtau).
Time frame: up to Week 16
Area under the plasma concentration-time curve from 0 to t (AUC0-t).
Time frame: up to Week 16
Occurrence of anti-drug antibodies (ADA) to CM326.
Keymed Biosciences Co.Ltd
Industry
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Multiple Ascending Doses of CM326 Injection by Subcutaneous Administration in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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