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NCT Number: NCT07518589

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.
  • 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.

Treatment and study plan

CMS-D008

Biological

Healthy and overweight or obese participants

Placebo

Drug

Healthy and overweight or obese participants

Primary outcomes

  1. Change from baseline to each visit point in vital signs (temperature, blood pressure, heart rate, respiratory rate)

    Time frame: through study completion,an average of 0.6 years

    Measured using electronic sphygmomanometer/thermometer according to standard procedures, record actual values at each visit point, and assess abnormal values.

  2. Incidence rate of abnormal findings in comprehensive systemic physical examination

    Time frame: through study completion,an average of 0.6 years

    Record abnormal physical examination findings by system (cardiovascular, respiratory, digestive, etc.), summarize the number and incidence rate of abnormalities in each system, and categorize them as related or unrelated to the study drug.

  3. Hematology, biochemistry, and urinalysis laboratory test indicators

    Time frame: through study completion,an average of 0.6 years

    The tests include complete blood count (WBC, RBC, Hb, etc.), blood biochemistry (ALT, AST, Cr, etc.), and urinalysis; changes from baseline were calculated, and the incidence of abnormal values was summarized according to CTCAE 6.0 grading.

  4. 12-lead electrocardiogram QTc interval, heart rate, and incidence of morphological abnormalities

    Time frame: through study completion,an average of 0.6 years

    Collected using standard 12-lead ECG equipment, interpreted by a central laboratory, with the number and incidence rate of QTc interval changes, heart rate abnormalities, and morphological abnormalities (such as premature beats, ST-T changes) summarized.

Secondary outcomes

  1. Maximum plasma drug concentration (Cmax)

    Time frame: Through 48 hours post-dose

    Calculate the maximum observed plasma concentration from the plasma drug concentration-time curve after administration using non-compartmental analysis (NCA), unit: ng/mL

  2. Tmax

    Time frame: Through 48 hours post-dose

    Using non-compartmental analysis (NCA) to calculate the time to reach Cmax after drug administration, unit: h

  3. Area under the curve (AUC0-t)

    Time frame: Through 48 hours post-dose

    Calculate the area under the concentration-time curve from time of administration (0 h) to the last quantifiable concentration time point (t) using non-compartmental analysis (NCA), unit: ng·h/mL

Sponsors and collaborators

Lead sponsor

Shenzhen Kangzhe Biotechnology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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