Testing different doses of HMS1005 in people 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

This will test different doses of a new medicine called HMS1005 in adults with type 2 diabetes to see if it's safe and how the body processes it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Hua Medicine Limited (Industry-sponsored)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT07568678 on ClinicalTrials.gov

What this trial studies

This Phase 1, multiple ascending dose, placebo-controlled interventional trial gives cohorts of adults with type 2 diabetes escalating doses of HMS1005 or matching placebo to characterize safety, tolerability, pharmacokinetics, and pharmacodynamics. Eligible participants are 18–65 years old with a BMI of 18–38 kg/m2 who are drug‑naïve or on stable antidiabetic regimens (including ≤2000 mg metformin) and agree to contraception requirements. The study will collect adverse event data, laboratory tests, ECGs, vital signs, and serial blood samples for PK/PD analysis to define dose–exposure relationships and early biological effects. All enrollment and dosing are conducted at a clinical pharmacology site in Miami, Florida.

Who should consider this trial

Good fit: Adults aged 18–65 with type 2 diabetes and BMI 18–38 kg/m2 who are drug‑naïve or on stable antidiabetic therapy (including ≤2000 mg metformin) and who meet health and contraception requirements.

Not a fit: People with unstable medical conditions, advanced diabetes requiring insulin, pregnant or lactating women, or those outside the specified age or BMI ranges are unlikely to be eligible or to benefit from this early‑phase trial.

Why it matters

Potential benefit: If HMS1005 is safe and has favorable pharmacologic effects, it could offer a new treatment option to help improve glucose control for people with type 2 diabetes.

How similar studies have performed: This is an early Phase 1 trial of HMS1005 itself and the molecule is unproven in humans, although other novel diabetes agents in development have shown mixed success.

Eligibility criteria

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.

Where this trial is running

Miami, Florida

• Clinical Pharmacology of Miami — Miami, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Jesus Olivia

Conditions Type 2 Diabetes