RecruitingType 2 Diabetes

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

Eligible age

18–65 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

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

Sponsor: Hua Medicine Limited

✓ 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).

✕ 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).

Miami

Source: ClinicalTrials.gov · NCT07568678 · last updated 2026-05-06