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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Phase 1, Multiple Ascending Dose Study to Evaluate HMS1005 in Participants With Type 2 Diabetes

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple- Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS1005 in Participants With Type 2 Diabetes

A Phase 1, Multiple Ascending Dose Study to Evaluate HMS1005 in Participants With Type 2 Diabetes (NCT07568678) is a Phase 1 interventional studying Type 2 Diabetes, sponsored by Hua Medicine Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The study is to assess the safety, pharmacokinetics, and pharmacodynamic profile of HMS1005 in patient with diabetes

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Type 2 Diabetes, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Males or females, of any race, between 18 and 65 years of age, inclusive. 2. Body mass index between 18 and 38.0 kg/m2, inclusive. 3. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 3. 4. T2DM, as determined by the ADA Standard Care Diagnostic Criteria 2025, and - are drug naïve, treated with diet and exercise, or - have been on a stable dose of ≤2000 mg metformin for ≥1 month, and/or - have been on a stable dose of other antidiabetic medications for ≥90 days. 5. Except for findings consistent with T2DM, in good health, determined from medical history, 12-lead electrocardiogram (ECG), vital signs measurements, clinical laboratory evaluations, and physical examinations at screening and/or check in, as assessed by the Investigator (or designee). 6. Doses of antihypertensive and lipid-lowering therapies must be stable for 30 days prior to screening and remain unchanged during the study unless necessary to protect participant safety on an emergency basis (e.g., hypertensive crisis). 7. Glycated hemoglobin between 7.0% and 10.5%, inclusive. 8. Fasting plasma glucose between 126 and 240 mg/dL, inclusive. Testing may be repeated once, at the discretion of the Investigator (or designee). 9. Able to comprehend and willing to sign an ICF and to abide by the study restrictions. Who Should NOT Join This Trial: 1. Type 1 diabetes mellitus, maturity onset diabetes of the young, or diabetes mellitus caused by damage to the pancreas or any other condition (eg, acromegaly or Cushing's syndrome). 2. Diabetic neuropathy, retinopathy, or nephropathy. 3. History of acute diabetic complications such as diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, lactic acidosis, or hyperosmolar nonketotic coma within the 6 months prior to screening, or chronic metabolic acidosis. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Males or females, of any race, between 18 and 65 years of age, inclusive. 2. Body mass index between 18 and 38.0 kg/m2, inclusive. 3. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 3. 4. T2DM, as determined by the ADA Standard Care Diagnostic Criteria 2025, and * are drug naïve, treated with diet and exercise, or * have been on a stable dose of ≤2000 mg metformin for ≥1 month, and/or * have been on a stable dose of other antidiabetic medications for ≥90 days. 5. Except for findings consistent with T2DM, in good health, determined from medical history, 12-lead electrocardiogram (ECG), vital signs measurements, clinical laboratory evaluations, and physical examinations at screening and/or check in, as assessed by the Investigator (or designee). 6. Doses of antihypertensive and lipid-lowering therapies must be stable for 30 days prior to screening and remain unchanged during the study unless necessary to protect participant safety on an emergency basis (e.g., hypertensive crisis). 7. Glycated hemoglobin between 7.0% and 10.5%, inclusive. 8. Fasting plasma glucose between 126 and 240 mg/dL, inclusive. Testing may be repeated once, at the discretion of the Investigator (or designee). 9. Able to comprehend and willing to sign an ICF and to abide by the study restrictions. Exclusion Criteria: 1. Type 1 diabetes mellitus, maturity onset diabetes of the young, or diabetes mellitus caused by damage to the pancreas or any other condition (eg, acromegaly or Cushing's syndrome). 2. Diabetic neuropathy, retinopathy, or nephropathy. 3. History of acute diabetic complications such as diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, lactic acidosis, or hyperosmolar nonketotic coma within the 6 months prior to screening, or chronic metabolic acidosis. 4. History of severe hypoglycemia, defined as severe cognitive impairment requiring external assistance for recovery within 3 months prior to dosing; or recurrent hypoglycemia (Level 2), defined as ≥2 episodes within 3 months prior to dosing; or ADA Level 3 hypoglycemia within 6 months prior to dosing. 5. Hypoglycemia unawareness or asymptomatic hypoglycemia. 6. Clinically significant history of liver disease (eg, hepatitis and cirrhosis) within 1 year prior to screening. 7. Clinically significant history of renal disease. Mild to moderate chronic kidney disease is permitted. 8. Clinically significant history of cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart disease within 1 year prior to screening. Managed hypertension is permitted (defined as systolic blood pressure \<160 mmHg and/or diastolic blood pressure \<100 mmHg). 9. Clinically significant history of any central nervous system or psychiatric disease, including transient ischemic attack, stroke, seizure disorder, depression, or behavioral disturbances within 1 year prior to screening. 10. Clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have had gastric bypass surgery. 11. Clinically significant or unstable history of any hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). 12. Known or active malignancy, except basal cell carcinoma and cutaneous squamous cell carcinoma. 13. Any hospital admission or major surgery within 90 days prior to screening. 14. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the Investigator (or designee). 15. Fasting C peptide \< 0.81 ng/mL. 16. Alanine aminotransferase, aspartate aminotransferase, or gamma glutamyl transferase \>2 × the upper limit of normal (ULN); or total bilirubin \>1.5× ULN. Testing may be repeated once, at the discretion of the Investigator (or designee). 17. Uncontrolled hypertriglyceridemia \> 500 mg/dL. 18. Estimated glomerular filtration rate ≤ 45 mL/minutes/1.73 m2, as calculated using the 2021 Chronic Kidney Disease Epidemiology equation. 19. Hemoglobin ≤120 g/L (male) or ≤110 g/L (female). 20. QT interval corrected for heart rate using Fridericia's method \> 450 msec. 21. Positive hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency (HIV 1 and HIV 2) antibodies and p24 antigen. 22. Positive pregnancy test. 23. Use of insulin, sulfonylureas, GLP-1 agonists, DPP-4 inhibitors, SGLT2 inhibitor and glinides (eg, repaglinide and nateglinide). 24. Use of any strong or moderate cytochrome P450 (CYP) 3A4 inducers within 28 days prior to dosing or any strong or moderate CYP3A4 inhibitors within 7 days or 5 half-lives, whichever is longer, prior to dosing (Appendix 5). 25. Use of any P glycoprotein inducers within 14 days prior to dosing or any P glycoprotein inhibitors within 5 days or 5 half-lives, whichever is longer, prior to dosing (Appendix 6). 26. Use of any carboxylesterase 2 inhibitors within 5 days or 5 half-lives, whichever is longer, prior to dosing (Appendix 7). 27. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days. 28. Positive alcohol test result, or positive urine drug screen (confirmed by repeat) at screening or check in. 29. Current drug abuse, defined as the use of any illegal substance or misuse or excessive used of over the counter or prescription drugs; or current alcohol abuse, defined as the inability to stop or control alcohol use, despite adverse social or health consequences. 30. Consumption of alcohol, or caffeine containing foods or beverages within 48 hours, or foods and beverages containing grapefruit or Seville oranges within 7 days prior to check in. 31. Use of tobacco or nicotine containing products within 1 month prior to screening. 32. Receipt or donation of \> 1 unit (approximately 450 mL) of blood products within 3 months prior to screening. 33. Poor peripheral venous access. 34. Participants who, in the opinion of the Investigator (or designee), should not participate in this study.

Treatments Being Tested

DRUG

HMS1005

The investigational medicinal products (IMPs) HMS1005 ER tablets

DRUG

Matching placebo

Matching placebo

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Clinical Pharmacology of Miami
Miami, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07568678), the sponsor (Hua Medicine Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07568678 clinical trial studying?

The study is to assess the safety, pharmacokinetics, and pharmacodynamic profile of HMS1005 in patient with diabetes The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07568678?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07568678?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07568678. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07568678. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.