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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Evaluate the Safety and Tolerability; Healthy and Overweight or Obese Participants
• Intervention / Treatment: Biological: CMS-D008; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD:CMS-D008; 5 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo	Biological: CMS-D008; Healthy and overweight or obese participants
Placebo Comparator: SAD: Placebo; 5 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo	Drug: Placebo; Healthy and overweight or obese participants
Experimental: MAD: CMS-D008; 3 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo	Biological: CMS-D008; Healthy and overweight or obese participants
Placebo Comparator: MAD: Placebo; 3 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo	Drug: Placebo; Healthy and overweight or obese participants
Experimental: Expansion study: CMS-D008; 2 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo	Biological: CMS-D008; Healthy and overweight or obese participants
Placebo Comparator: Expansion study: Placebo; 2 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo	Drug: Placebo; Healthy and overweight or obese participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma drug concentration (Cmax)	Calculate the maximum observed plasma concentration from the plasma drug concentration-time curve after administration using non-compartmental analysis (NCA), unit: ng/mL	Through 48 hours post-dose
Tmax	Using non-compartmental analysis (NCA) to calculate the time to reach Cmax after drug administration, unit: h	Through 48 hours post-dose
Area under the curve (AUC0-t)	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	Through 48 hours post-dose

Collaborators and Investigators

• Sponsor: Shenzhen Kangzhe Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 2, 2026
• Primary Completion (Estimated): November 24, 2027
• Study Completion (Estimated): December 10, 2027

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: safety; Phase 1 clinical study; fat loss
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight
• Other Study ID Numbers: D008-01-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No