NCT07518589

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Shenzhen Kangzhe Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Evaluate the Safety and Tolerability
• Healthy and Overweight or Obese Participants

Interventions

Type	Name	Description
BIOLOGICAL	CMS-D008	Healthy and overweight or obese participants
DRUG	Placebo	Healthy and overweight or obese participants

Timeline

• Start date: 2026-04-02
• Primary completion: 2027-11-24
• Completion: 2027-12-10
• First posted: 2026-04-08
• Last updated: 2026-04-08