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

NCT07518589 | Not Yet Recruiting Phase 1

• 1 other identifier: D008-01-001
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Phase 1 clinical study; safety; fat loss

Outcome Measures

Primary Outcomes (4)

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

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

  through study completion,an average of 0.6 years

• Incidence rate of abnormal findings in comprehensive systemic physical examination

  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.

  through study completion,an average of 0.6 years

• Hematology, biochemistry, and urinalysis laboratory test indicators

  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.

  through study completion,an average of 0.6 years

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

  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.

  through study completion,an average of 0.6 years

Secondary Outcomes (3)

• Maximum plasma drug concentration (Cmax)

  Through 48 hours post-dose

• Tmax

  Through 48 hours post-dose

• Area under the curve (AUC0-t)

  Through 48 hours post-dose

Study Arms (6)

SAD:CMS-D008

EXPERIMENTAL

5 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo

Biological: CMS-D008

SAD: Placebo

PLACEBO COMPARATOR

5 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo

Drug: Placebo

MAD: CMS-D008

EXPERIMENTAL

3 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo

Biological: CMS-D008

MAD: Placebo

PLACEBO COMPARATOR

3 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo

Drug: Placebo

Expansion study: CMS-D008

EXPERIMENTAL

2 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo

Biological: CMS-D008

Expansion study: Placebo

PLACEBO COMPARATOR

2 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo

Drug: Placebo

Interventions

Placebo DRUG

Healthy and overweight or obese participants

Expansion study: Placebo; MAD: Placebo; SAD: Placebo

CMS-D008 BIOLOGICAL

Healthy and overweight or obese participants

Expansion study: CMS-D008; MAD: CMS-D008; SAD:CMS-D008

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Kangzhe Biotechnology Co., Ltd.: lead

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 8, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): November 24, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04