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NOT YET RECRUITING
NCT07518589
PHASE1

Phase 1 Study of Ascending Doses of CMS-D008 in Healthy and Overweight/Obese Adults

Sponsor: Shenzhen Kangzhe Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-04-02

Completion Date

2027-12-10

Last Updated

2026-04-08

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

CMS-D008

Healthy and overweight or obese participants

DRUG

Placebo

Healthy and overweight or obese participants