drugset / Trial / NCT07518589

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

NCT07518589 ↗

Phase 1 Not yet recruiting 110 enrolled Shenzhen Kangzhe Biotechnology Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2026-04-02
Primary completion
2027-11-24
Completion
2027-12-10

Drugs

EvaluationDrugModalityDoseRoute
Subject CMS-D008 Unknown — Subcutaneous

Indications

No indication recorded.