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..
Trial summary
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… Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangzhe Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07518589
- Acronym / sponsor ID
- D008-01-001
- Keywords
- Phase 1 clinical study, safety, fat loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shenzhen Kangzhe Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2026 (estimated)
- Primary completion
- 24 Nov 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SAD:CMS-D008 | Experimental | Biological: CMS-D0085 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo |
| SAD: Placebo | Placebo comparator | Drug: Placebo5 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo |
| MAD: CMS-D008 | Experimental | Biological: CMS-D0083 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo |
| MAD: Placebo | Placebo comparator | Drug: Placebo3 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo |
| Expansion study: CMS-D008 | Experimental | Biological: CMS-D0082 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo |
| Expansion study: Placebo | Placebo comparator | Drug: Placebo2 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMS-D008Healthy and overweight or obese participants | Biological | Expansion study: CMS-D008, MAD: CMS-D008, SAD:CMS-D008 |
| PlaceboHealthy and overweight or obese participants | Drug | Expansion study: Placebo, MAD: Placebo, SAD: Placebo |
Primary outcome
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
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 examination
Time frame: through 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 indicators
Time frame: through 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 abnormalities
Time frame: through 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
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..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.