RecruitingPhase 1

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

United States40 participantsStarted 2025-12-04

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. 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).

Exclusion criteria

✕. 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).
✕. Diabetic neuropathy, retinopathy, or nephropathy.
✕. 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.
✕. Hypoglycemia unawareness or asymptomatic hypoglycemia.
✕. Clinically significant history of liver disease (eg, hepatitis and cirrhosis) within 1 year prior to screening.
✕. Clinically significant history of renal disease. Mild to moderate chronic kidney disease is permitted.
✕. 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).

What they're measuring

Incidence of adverse events

Timeframe: From enrollment to the end of treatment at Day 19

Area under the plasma concentration versus time curve (AUC)

Timeframe: Single-dose: Day 1-3 steady-state: Day 14-17

Maximum observed concentration (Cmax)

Timeframe: Single-dose: Day 1-3 steady-state: Day 14-17

Time of the maximum observed concentration (Tmax)

Timeframe: Single-dose: Day 1-3 steady-state: Day 14-17

Apparent terminal elimination half life (t1/2)

Timeframe: Single-dose: Day 1-3 steady-state: Day 14-17

Trial details

NCT IDNCT07568678

SponsorHua Medicine Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-13

Contact for this trial

Jesus Olivia

305-817-2900 joliva@ErgClinical.com

View on ClinicalTrials.gov More Type 2 Diabetes trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. 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).

Exclusion criteria

✕. 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).
✕. Diabetic neuropathy, retinopathy, or nephropathy.
✕. 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.
✕. Hypoglycemia unawareness or asymptomatic hypoglycemia.
✕. Clinically significant history of liver disease (eg, hepatitis and cirrhosis) within 1 year prior to screening.
✕. Clinically significant history of renal disease. Mild to moderate chronic kidney disease is permitted.
✕. 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).

What they're measuring

Incidence of adverse events

Timeframe: From enrollment to the end of treatment at Day 19

Area under the plasma concentration versus time curve (AUC)

Timeframe: Single-dose: Day 1-3 steady-state: Day 14-17

Maximum observed concentration (Cmax)

Timeframe: Single-dose: Day 1-3 steady-state: Day 14-17

Time of the maximum observed concentration (Tmax)

Timeframe: Single-dose: Day 1-3 steady-state: Day 14-17

Apparent terminal elimination half life (t1/2)

Timeframe: Single-dose: Day 1-3 steady-state: Day 14-17