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

NCT07518589 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-04-08

No results posted yet for this study

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

BIOLOGICAL

CMS-D008

Healthy and overweight or obese participants

DRUG

Placebo

Healthy and overweight or obese participants

Sponsors & Collaborators

  • Shenzhen Kangzhe Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07518589 on ClinicalTrials.gov