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

NCT07568678 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HMM0126
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse events

  incidence and severity of adverse events from Day1 to Day 19

  From enrollment to the end of treatment at Day 19

• Area under the plasma concentration versus time curve (AUC)

  Measure area under the concentration-time curve from time 0 to 72 hours postdose of HM-002-1005 in plasma after single-dose and at steady-state

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

• Maximum observed concentration (Cmax)

  Cmax of HM-002-1005 in plasma after single and multiple dose

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

• Time of the maximum observed concentration (Tmax)

  Time of the maximum observed concentration (Tmax) of HM-002-1005

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

• Apparent terminal elimination half life (t1/2)

  t1/2 of HM-002-1005 in plasma

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

Secondary Outcomes (2)

• Glucose concentration

  Day -1 and 14

• Glucose time in range (70-180 mg/dL) %

  From Day -10 (baseline) to Day 17

Other Outcomes (4)

• Insulin concentration

  Day -2, -1, 13, and 14

• C-peptide concentration

  Day -2, -1, 13, and 14

• Glucagon concentration

  Day -2, -1, 13, and 14

Study Arms (5)

123 mg HMS1005 (1 x 123 mg tablet) and matching placebo

EXPERIMENTAL

active vs placebo: 6 to 2

Drug: HMS1005; Drug: Matching placebo

184.5 mg HMS1005 (1 x 184.5 mg tablet) and matching placebo

EXPERIMENTAL

active vs placebo: 6 to 2

Drug: HMS1005; Drug: Matching placebo

369 mg HMS1005 (2 x 184.5 mg tablet) and matching placebo

EXPERIMENTAL

active vs placebo: 6 to 2

Drug: HMS1005; Drug: Matching placebo

492 mg HMS1005 (2 x 246 mg tablet) and matching placebo

EXPERIMENTAL

active vs placebo: 6 to 2

Drug: HMS1005; Drug: Matching placebo

246 mg HMS1005 (1 x 246 mg tablet) or placebo

EXPERIMENTAL

active vs placebo: 6 to 2

Drug: HMS1005; Drug: Matching placebo

Interventions

HMS1005 DRUG

The investigational medicinal products (IMPs) HMS1005 ER tablets

123 mg HMS1005 (1 x 123 mg tablet) and matching placebo; 184.5 mg HMS1005 (1 x 184.5 mg tablet) and matching placebo; 246 mg HMS1005 (1 x 246 mg tablet) or placebo; 369 mg HMS1005 (2 x 184.5 mg tablet) and matching placebo; 492 mg HMS1005 (2 x 246 mg tablet) and matching placebo

Matching placebo DRUG

Matching placebo

123 mg HMS1005 (1 x 123 mg tablet) and matching placebo; 184.5 mg HMS1005 (1 x 184.5 mg tablet) and matching placebo; 246 mg HMS1005 (1 x 246 mg tablet) or placebo; 369 mg HMS1005 (2 x 184.5 mg tablet) and matching placebo; 492 mg HMS1005 (2 x 246 mg tablet) and matching placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• 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.
• Any hospital admission or major surgery within 90 days prior to screening.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the Investigator (or designee).
• Fasting C peptide \< 0.81 ng/mL.

Sponsors & Collaborators

• Hua Medicine Limited: lead
• TigerMed: collaborator

Study Sites (1)

Clinical Pharmacology of Miami

Miami, Florida, 33172, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Jesus Olivia

CONTACT

305-817-2900; joliva@ErgClinical.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Placebo-Controlled, Double-Blind, Multiple- Dose Escalation Study. About 40 participants will be assigned to 5 groups with 8 participants in each group. Participants in each group will be randomized to receive HMS1005 treatment or matching placebo with 6:2 ratio. The study will start with the lowest dose level. Safety data will be reviewed after each cohort before proceeding the the next higher dose level.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: May 6, 2026
• Study Start: December 4, 2025
• Primary Completion (Estimated): August 13, 2026
• Study Completion (Estimated): October 13, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)