Clinical trial

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

Opening soon · Phase 1 · 0 countries · Registry ID NCT07518589

Opening soonPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 55 Years
SexAll
Healthy volunteersAccepted
ConditionEvaluate the Safety and Tolerability, Healthy and Overweight or Obese Participants

Full registry criteria

Inclusion Criteria: 1. 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. 2. Male or female aged 18-56 years (inclusive) 3. Body mass index (BMI) ≥23 kg/m2 at screening, with stable body weight in the past 4 months 4. Glycated hemoglobin (HbA1c) \< 6.5% and fasting plasma glucose \< 7 mmol/L at screening. 5. 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: 1. 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. 2. 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. 3. Any skin conditions that may interfere with the assessment of injection-site reactions. 4. Use of any siRNA agent in the prior 12 months 5. Use of glucagon-like peptide-1 (GLP-1) receptor agonists and other weight-loss medications in the past 6 months. 6. 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. 7. 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.

Treatments and study arms

CMS-D008

Biological

Healthy and overweight or obese participants

Placebo

Drug

Healthy and overweight or obese participants

Primary outcomes

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

Incidence rate of abnormal findings in comprehensive systemic physical examinationthrough 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.

Hematology, biochemistry, and urinalysis laboratory test indicatorsthrough 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.

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

Study locations

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No public site location was included in this record. Check the original registry for updates.