Health TrialsbyHealthPanel

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

ConditionsEvaluate the Safety and TolerabilityHealthy and Overweight or Obese Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShenzhen Kangzhe Biotechnology Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • CMS-D008

    Biological/Vaccine

    Healthy and overweight or obese participants

  • Placebo

    Drug

    Healthy and overweight or obese participants

Treatment groups

110 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: SAD:CMS-D008Experimental treatment 1 intervention
Group B: SAD: PlaceboPlacebo comparator 1 intervention
Group C: MAD: CMS-D008Experimental treatment 1 intervention
Group D: MAD: PlaceboPlacebo comparator 1 intervention
Group E: Expansion study: CMS-D008Experimental treatment 1 intervention
Group F: Expansion study: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion,an average of 0.6 years
2

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.

Time frame
through study completion,an average of 0.6 years
3

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.

Time frame
through study completion,an average of 0.6 years
4

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.

Time frame
through study completion,an average of 0.6 years

Secondary outcomes

1

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

Time frame
Through 48 hours post-dose
2

Tmax

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

Time frame
Through 48 hours post-dose
3

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

Time frame
Through 48 hours post-dose

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Kangzhe Biotechnology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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