Evaluate the Safety and TolerabilityPhase 1NCT07518589

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

A Phase 1 study testing CMS-D008 in people with Evaluate the Safety and Tolerability and Healthy and Overweight or Obese Participants, run by Shenzhen Kangzhe Biotechnology Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Evaluate the Safety and Tolerability, Healthy and Overweight or Obese Participants
What is being tested?: CMS-D008
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 110 participants
Where: No sites listed yet
Study dates: 2 Apr 2026to 10 Dec 2027
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

About this study

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

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
Being tested: CMS-D008, Placebo
Keywords: Phase 1 clinical study, safety, fat loss
Medical subject headings: Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CMS-D008Biological
Healthy and overweight or obese participants
PlaceboDrug
Healthy and overweight or obese participants

Study groups in NCT07518589
Study group	Role	What they receive
SAD:CMS-D008	Experimental	5 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo Receives: Biological: CMS-D008
SAD: Placebo	Placebo comparator	5 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo Receives: Drug: Placebo
MAD: CMS-D008	Experimental	3 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo Receives: Biological: CMS-D008
MAD: Placebo	Placebo comparator	3 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo Receives: Drug: Placebo
Expansion study: CMS-D008	Experimental	2 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo Receives: Biological: CMS-D008
Expansion study: Placebo	Placebo comparator	2 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion,an average of 0.6 years

Secondary outcomes (3)

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
Measured: Through 48 hours post-dose
Tmax
Using non-compartmental analysis (NCA) to calculate the time to reach Cmax after drug administration, unit: h
Measured: 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
Measured: Through 48 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 202610 Dec 2027

First posted8 Apr 2026
Study start2 Apr 2026 (estimated)
Primary completion24 Nov 2027 (estimated)
Study completion10 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Evaluate the Safety and TolerabilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 110 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07518589
Sponsor's protocol ID: D008-01-001
Status last verified: Apr 2026
First submitted: 20 Mar 2026
Last updated: 8 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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