Type 2 DiabetesPhase 1NCT07568678
A Phase 1, Multiple Ascending Dose Study to Evaluate HMS1005 in Participants With Type 2 Diabetes
A Phase 1 study testing HMS1005 in people with Type 2 Diabetes, run by Hua Medicine Limited at 1 site in United States.
Trial summary
The study is to assess the safety, pharmacokinetics, and pharmacodynamic profile of HMS1005 in patient with diabetes Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HMS1005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2025to 13 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Estimated glomerular filtration rate ≤ 45 mL/minutes/1.73 m2, as calculated using the 2021 Chronic Kidney Disease Epidemiology equation.
- Hemoglobin ≤120 g/L (male) or ≤110 g/L (female).
- QT interval corrected for heart rate using Fridericia's method > 450 msec.
- Positive hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency (HIV 1 and HIV 2) antibodies and p24 antigen.
- Positive pregnancy test.
- 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.
- Poor peripheral venous access.
- Participants who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical Pharmacology of Miami
Miami, Florida, 33172
Cheryl Duggan, 305-817-2900, cduggan@ergclinical.com
Alexander N Prezioso, MD
About this study
Official title: 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
- Conditions
- Type 2 Diabetes
- Being tested
- HMS1005, Matching placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMS1005Drug
The investigational medicinal products (IMPs) HMS1005 ER tablets
Matching placeboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 123 mg HMS1005 (1 x 123 mg tablet) and matching placebo | Experimental | active vs placebo: 6 to 2 Receives: 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 Receives: Drug: HMS1005; Drug: Matching placebo |
| 369 mg HMS1005 (2 x 184.5 mg tablet) and matching placebo | Experimental | active vs placebo: 6 to 2 Receives: Drug: HMS1005; Drug: Matching placebo |
| 492 mg HMS1005 (2 x 246 mg tablet) and matching placebo | Experimental | active vs placebo: 6 to 2 Receives: Drug: HMS1005; Drug: Matching placebo |
| 246 mg HMS1005 (1 x 246 mg tablet) or placebo | Experimental | active vs placebo: 6 to 2 Receives: Drug: HMS1005; Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
incidence and severity of adverse events from Day1 to Day 19
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Single-dose: Day 1-3 steady-state: Day 14-17
Secondary outcomes (2)
Glucose concentration
Measure serum glucose concentration over 24 hours after dosing
Measured: Day -1 and 14
Glucose time in range (70-180 mg/dL) %
Percentage of glucose time in range (70-180 mg/dL) will measured by continous glucose monitor
Measured: From Day -10 (baseline) to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start4 Dec 2025
- Primary completion13 Aug 2026 (estimated)
- Study completion13 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hua Medicine Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TigerMed
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568678
- Sponsor's protocol ID
- HMM0126
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07568678
- Acronym / sponsor ID
- HMM0126
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hua Medicine LimitedIndustry (pharma, biotech, devices)
- Collaborators
- TigerMed
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 13 Aug 2026 (estimated)
- Study completion
- 13 Oct 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is to assess the safety, pharmacokinetics, and pharmacodynamic profile of HMS1005 in patient with diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 123 mg HMS1005 (1 x 123 mg tablet) and matching placebo | Experimental | Drug: HMS1005, Drug: Matching placeboactive vs placebo: 6 to 2 |
| 184.5 mg HMS1005 (1 x 184.5 mg tablet) and matching placebo | Experimental | Drug: HMS1005, Drug: Matching placeboactive vs placebo: 6 to 2 |
| 369 mg HMS1005 (2 x 184.5 mg tablet) and matching placebo | Experimental | Drug: HMS1005, Drug: Matching placeboactive vs placebo: 6 to 2 |
| 492 mg HMS1005 (2 x 246 mg tablet) and matching placebo | Experimental | Drug: HMS1005, Drug: Matching placeboactive vs placebo: 6 to 2 |
| 246 mg HMS1005 (1 x 246 mg tablet) or placebo | Experimental | Drug: HMS1005, Drug: Matching placeboactive vs placebo: 6 to 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMS1005The investigational medicinal products (IMPs) HMS1005 ER tablets | Drug | 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 placeboMatching placebo | Drug | 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 |
Primary outcome
Incidence of adverse events
Time frame: From enrollment to the end of treatment at Day 19
incidence and severity of adverse events from Day1 to Day 19
Area under the plasma concentration versus time curve (AUC)
Time frame: Single-dose: Day 1-3 steady-state: Day 14-17
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
Maximum observed concentration (Cmax)
Time frame: Single-dose: Day 1-3 steady-state: Day 14-17
Cmax of HM-002-1005 in plasma after single and multiple dose
Time of the maximum observed concentration (Tmax)
Time frame: Single-dose: Day 1-3 steady-state: Day 14-17
Time of the maximum observed concentration (Tmax) of HM-002-1005
Apparent terminal elimination half life (t1/2)
Time frame: Single-dose: Day 1-3 steady-state: Day 14-17
t1/2 of HM-002-1005 in plasma
2 secondary outcomes
Glucose concentration
Time frame: Day -1 and 14
Glucose time in range (70-180 mg/dL) %
Time frame: From Day -10 (baseline) to Day 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMS1005 in people with Type 2 Diabetes, run by Hua Medicine Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesus Olivia (305-817-2900, joliva@ErgClinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: From enrollment to the end of treatment at Day 19). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.