Tests HMS1005 for safety in adults with type 2 diabetes

Trial details

Who runs it

Hua Medicine Limited

Trial code

NCT07568678

Record updated

6 May 2026

Original description

The study is to assess the safety, pharmacokinetics, and pharmacodynamic profile of HMS1005 in patient with diabetesRead full original descriptionShow less

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

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

Inclusion: Males or females, of any race, between 18 and 65 years of age, inclusive; Body mass index between 18 and 38.0 kg/m2, inclusive; Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 3; 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; 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); 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); Glycated hemoglobin between 7.0% and 10.5%, inclusive; Fasting plasma glucose between 126 and 240 mg/dL, inclusive. Testing may be repeated once, at the discretion of the Investigator (or designee); Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion: 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; 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; Clinically significant history of liver disease (eg, hepatitis and cirrhosis) within 1 year prior to screening; 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); 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; Clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have had gastric bypass surgery; Any hospital admission or major surgery within 90 days prior to screening; Use of insulin, sulfonylureas, GLP-1 agonists, DPP-4 inhibitors, SGLT2 inhibitor and glinides (eg, repaglinide and nateglinide); 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); 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); Use of any carboxylesterase 2 inhibitors within 5 days or 5 half-lives, whichever is longer, prior to dosing (Appendix 7); Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days; Positive alcohol test result, or positive urine drug screen (confirmed by repeat) at screening or check in; 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; 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; Use of tobacco or nicotine containing products within 1 month prior to screening; Receipt or donation of > 1 unit (approximately 450 mL) of blood products within 3 months prior to screening; 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); Clinically significant history of renal disease. Mild to moderate chronic kidney disease is permitted; 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); Known or active malignancy, except basal cell carcinoma and cutaneous squamous cell carcinoma; History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the Investigator (or designee); Estimated glomerular filtration rate ≤ 45 mL/minutes/1.73 m2, as calculated using the 2021 Chronic Kidney Disease Epidemiology equation; Positive hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency (HIV 1 and HIV 2) antibodies and p24 antigen; 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); Uncontrolled hypertriglyceridemia > 500 mg/dL; Hemoglobin ≤120 g/L (male) or ≤110 g/L (female); QT interval corrected for heart rate using Fridericia's method > 450 msec; Diabetic neuropathy, retinopathy, or nephropathy; Hypoglycemia unawareness or asymptomatic hypoglycemia; Fasting C peptide < 0.81 ng/mL; Positive pregnancy test; Poor peripheral venous access; Participants who, in the opinion of the Investigator (or designee), should not participate in this study.

ClinicalTrials.gov NCT07568678