CMS-D008
BiologicalHealthy and overweight or obese participants
NCT Number: NCT07518589
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.
Trial opening soon.
Get Notified18 year–55 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Healthy and overweight or obese participants
Healthy and overweight or obese participants
Time frame: through study completion,an average of 0.6 years
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
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
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
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 48 hours post-dose
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
Using non-compartmental analysis (NCA) to calculate the time to reach Cmax after drug administration, unit: h
Time frame: Through 48 hours post-dose
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
Shenzhen Kangzhe Biotechnology Co., Ltd.
Industry
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of Ascending Doses of CMS-D008 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Adults and Adults Living With Overweight or Obesity
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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