This is a randomized, open-label, parallel-controlled study to compare the PK, safety, and immunogenicity of CM326 administered via different delivery devices in healthy subjects.
Participants [c1.1]must be informed of the study before it begins, fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;
Healthy male participants aged 18 to 55 years;
Body weight between 55.0 and 85.0 kg, and body mass index between 19.0 and 26.0 kg/m²;
Physical examination, vital signs, 12-lead electrocardiogram, laboratory tests, and other examination results are normal, or abnormal but without clinical significance;
History of chronic diseases or severe diseases involving the circulatory system, blood or hematopoietic system, respiratory system, endocrine system, urinary system, digestive system, immune system, psychiatric or nervous system, reproductive system, etc.;
Presence or suspicion of any active viral, bacterial, fungal, or parasitic infection within 14 days before dosing;
Participants who have undergone major surgery within 3 months before screening, or who plan to undergo major surgery during the study period;
History of allergies to drugs, food, etc., or Participants who may be allergic to the study drug or its components in the Investigator's judgment;
Parallel
CM326(formulation 1)
Drugsubcutaneous injection
CM326(formulation 2)
Drugsubcutaneous injection
Maximum concentration (Cmax)
To compare the Cmax of CM326 administered via different delivery devices
Area under the concentration-time curve from zero to infinity (AUCinf)
To compare the AUCinf of CM326 administered via different delivery devices
Time to maximum concentration (Tmax)
To characterize the Tmax of CM326 in healthy subjects
Area under the concentration-curve from zero to the last quantifiable concentration (AUClast)
To characterize the AUClast of CM326 in healthy subjects
Terminal elimination half-life (t1/2)
To characterize the t1/2 of CM326 in healthy subjects
Apparent clearance (CL/F)
To characterize the Vz/F of CM326 in healthy subjects
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This trial is not recruiting at the moment. You can still explore other options:
