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HMS1005 for Type 2 Diabetes

This study is testing a new drug called HMS1005 in people with Type 2 Diabetes. We want to learn more about how safe HMS1005 is, how your body processes it (pharmacokinetics), and what effects it has on your body (pharmacodynamics). You might be able to join if you are between 18 and 65 years old, have Type 2 Diabetes, and your body mass index (BMI) is between 18 and 38.0. The study will look at any side effects you might have and how much of the drug is in your blood over time. This study plans to enroll about 40 participants.

Study design
This is a Phase 1 study, meaning it's an early-stage trial. It will involve multiple doses of HMS1005 or a matching placebo (an inactive substance) and plans to include about 40 participants.
What's involved
The study measures side effects from when you enroll until the end of treatment on Day 19. Blood samples will be taken to measure drug levels on Day 1-3 and Day 14-17.
Compensation
Not stated in the trial record.
Follow-up
Side effects are measured from enrollment to the end of treatment on Day 19.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07568678

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Hua Medicine Limited
~40 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:HMS1005Matching placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over From enrollment to the end of treatment at Day 19
+4 more outcomes measured

Conditions

Type 2 Diabetes

Explore related trials

Type 2 Diabetes MellitusC Peptide

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Jesus Olivia
[email protected]
305-817-2900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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). 6. 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). 7. Glycated hemoglobin between 7.0% and 10.5%, inclusive. 8. Fasting plasma glucose between 126 and 240 mg/dL, inclusive. Testing may be repeated once, at the discretion of the Investigator (or designee). 9. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

What this trial measures

  • Incidence of adverse eventsFrom 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)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)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)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)Single-dose: Day 1-3 steady-state: Day 14-17

    t1/2 of HM-002-1005 in plasma