NCT07518589Not yet recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 20 Mar 2026
- Start date
- 2 Apr 2026
- Primary completion date
- 24 Nov 2027
- Lead sponsor
- Shenzhen Kangzhe Biotechnology Co., Ltd.
- Diseases
- Obesity
- NCT number
- NCT07518589
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 110
- From 2 Apr 2026 to the primary completion date, 24 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any siRNA agent in the prior 12 months
- Use of glucagon-like peptide-1 (GLP-1) receptor agonists and other weight-loss medications in the past 6 months.
- Use of any prescription or non-prescription drugs (including Chinese herbal medicines, vitamins, minerals, and dietary supplements, etc.) within 2 weeks before dosing or at least 5 elimination half-lives, whichever is longer.
Other illness
- History or presence of liver disease (except fatty liver disease), allergy, cardiovascular, endocrine (except primary obesity), neuropsychiatric, digestive, respiratory, hematological, immune, or genitourinary system major diseases.
- History or presence of endocrine diseases that may significantly affect body weight, or obesity caused by medication use, single gene mutation, or genetic obesity syndromes.
- Any skin conditions that may interfere with the assessment of injection-site reactions.
Lab values
- Participants with clinically significant abnormalities in vital signs, physical examination, laboratory tests, 12-lead ECG, and other auxiliary examinations at screening or baseline, who are considered by the investigator to be ineligible for enrollment.
Who the study is looking for
- Voluntarily participate in this study, sign the informed consent form, be able to understand and comply with all requirements and restrictions of the study, and complete the study in accordance with the protocol.
- Male or female aged 18-56 years (inclusive)
- Body mass index (BMI) ≥23 kg/m2 at screening, with stable body weight in the past 4 months
- Glycated hemoglobin (HbA1c) \< 6.5% and fasting plasma glucose \< 7 mmol/L at screening.
- Participants of childbearing potential (including their partners) have no plan to conceive, donate oocytes, or donate sperm from the date of signing the informed consent form until 7 months after the last study drug administration, and must comply with contraceptive requirements during this period
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.