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Not yet recruiting NCT07518589

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

Phase I Interventional Evaluate the Safety and Tolerability Healthy and Overweight or Obese Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CMS-D008, Placebo.
Who it may be relevant to
Registry conditions: Evaluate the Safety and Tolerability, Healthy and Overweight or Obese Participants. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Biological CMS-D008
    Healthy and overweight or obese participants
  • Drug Placebo
    Healthy and overweight or obese participants

Primary outcome measures

  • 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]
  • Incidence rate of abnormal findings in comprehensive systemic physical examination [Time frame: through study completion,an average of 0.6 years]
  • Hematology, biochemistry, and urinalysis laboratory test indicators [Time frame: through study completion,an average of 0.6 years]
  • 12-lead electrocardiogram QTc interval, heart rate, and incidence of morphological abnormalities [Time frame: through study completion,an average of 0.6 years]
Secondary outcome measures (3)
  • Maximum plasma drug concentration (Cmax) [Time frame: Through 48 hours post-dose]
  • Tmax [Time frame: Through 48 hours post-dose]
  • Area under the curve (AUC0-t) [Time frame: Through 48 hours post-dose]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07518589 · D008-01-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗