Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT07568678

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

Led by Hua Medicine Limited · Updated on 2026-05-06

40

Participants Needed

1

Research Sites

44 weeks

Total Duration

On this page

Sponsors

H

Hua Medicine Limited

Lead Sponsor

T

TigerMed

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females between 18 and 65 years old
  • Body mass index between 18 and 38.0 kg/m2
  • Females not pregnant or lactating; females of childbearing potential and males agree to use contraception
  • Diagnosed with type 2 diabetes by ADA 2025 criteria and either drug naive or treated with diet and exercise, or on stable doses of metformin 6000 mg for at least 1 month, or on stable doses of other antidiabetic drugs for at least 90 days
  • In good health except for type 2 diabetes, based on medical history, ECG, vital signs, labs, and physical exam
  • Stable doses of antihypertensive and lipid-lowering drugs for 30 days before screening and no changes during study unless emergency
  • Glycated hemoglobin between 7.0% and 10.5%
  • Fasting plasma glucose between 126 and 240 mg/dL
  • Able to understand and willing to sign informed consent and follow study rules
Not Eligible

You will not qualify if you...

  • Type 1 diabetes, maturity onset diabetes of the young, or diabetes caused by pancreatic damage or other conditions
  • Diabetic neuropathy, retinopathy, or nephropathy
  • Acute diabetic complications within 6 months before screening or chronic metabolic acidosis
  • Severe hypoglycemia or recurrent hypoglycemia episodes within 3 to 6 months before dosing
  • Hypoglycemia unawareness or asymptomatic hypoglycemia
  • Significant liver disease within 1 year before screening
  • Significant renal disease; mild to moderate kidney disease allowed
  • Significant cardiovascular disease within 1 year before screening; managed hypertension allowed
  • Significant central nervous system or psychiatric disease within 1 year before screening
  • Severe gastric emptying problems or gastric bypass surgery
  • Unstable or significant disorders of various systems as judged by investigator
  • Active malignancy except certain skin cancers
  • Recent hospital admission or major surgery within 90 days before screening
  • Significant allergies or intolerances
  • Fasting C peptide below 0.81 ng/mL
  • Elevated liver enzymes or bilirubin above specified limits
  • Uncontrolled high triglycerides above 500 mg/dL
  • Estimated glomerular filtration rate 6 45 mL/min/1.73 m2
  • Low hemoglobin below 120 g/L (male) or 110 g/L (female)
  • Prolonged QT interval above 450 msec
  • Positive hepatitis B, hepatitis C, HIV tests
  • Positive pregnancy test
  • Use of insulin, sulfonylureas, GLP-1 agonists, DPP-4 inhibitors, SGLT2 inhibitors, or glinides
  • Use of strong or moderate CYP3A4 inducers or inhibitors within specified time frames
  • Use of P glycoprotein or carboxylesterase 2 inhibitors within specified time frames
  • Participation in another investigational drug trial within 30 days
  • Positive alcohol or drug test at screening
  • Current drug or alcohol abuse
  • Recent consumption of alcohol, caffeine, grapefruit, or Seville oranges within specified times
  • Use of tobacco or nicotine products within 1 month before screening
  • Blood donation or transfusion exceeding 1 unit within 3 months before screening
  • Poor peripheral venous access
  • Investigator's judgment against participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinical Pharmacology of Miami

Miami, Florida, United States, 33172

Actively Recruiting

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Research Team

J

Jesus Olivia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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