This study is a first-in-human clinical trial of CMS-D008 conducted in Chinese healthy and overweight or obese adult participants, consisting of three parts: Part-1 Single Ascending Dose (SAD) study (hereinafter referred to as Part-1 SAD study), Part-2 Multiple Ascending Dose (MAD) study (hereinafter referred to as Part-2 MAD study), and Part-3 expansion study. The study aims to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) characteristics, and immunogenicity of single and multiple subcutaneous injections of CMS-D008 injection in Chinese healthy and overweight or obese adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
Healthy and overweight or obese participants
Healthy and overweight or obese participants
Change from baseline to each visit point in vital signs (temperature, blood pressure, heart rate, respiratory rate)
Measured using electronic sphygmomanometer/thermometer according to standard procedures, record actual values at each visit point, and assess abnormal values.
Time frame: through study completion,an average of 0.6 years
Incidence rate of abnormal findings in comprehensive systemic physical examination
Record abnormal physical examination findings by system (cardiovascular, respiratory, digestive, etc.), summarize the number and incidence rate of abnormalities in each system, and categorize them as related or unrelated to the study drug.
Time frame: through study completion,an average of 0.6 years
Hematology, biochemistry, and urinalysis laboratory test indicators
The tests include complete blood count (WBC, RBC, Hb, etc.), blood biochemistry (ALT, AST, Cr, etc.), and urinalysis; changes from baseline were calculated, and the incidence of abnormal values was summarized according to CTCAE 6.0 grading.
Time frame: through study completion,an average of 0.6 years
12-lead electrocardiogram QTc interval, heart rate, and incidence of morphological abnormalities
Collected using standard 12-lead ECG equipment, interpreted by a central laboratory, with the number and incidence rate of QTc interval changes, heart rate abnormalities, and morphological abnormalities (such as premature beats, ST-T changes) summarized.
Time frame: through study completion,an average of 0.6 years
Maximum plasma drug concentration (Cmax)
Calculate the maximum observed plasma concentration from the plasma drug concentration-time curve after administration using non-compartmental analysis (NCA), unit: ng/mL
Time frame: Through 48 hours post-dose
Tmax
Using non-compartmental analysis (NCA) to calculate the time to reach Cmax after drug administration, unit: h
Time frame: Through 48 hours post-dose
Area under the curve (AUC0-t)
Calculate the area under the concentration-time curve from time of administration (0 h) to the last quantifiable concentration time point (t) using non-compartmental analysis (NCA), unit: ng·h/mL
Time frame: Through 48 hours post-dose
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