Actively Recruiting
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
Led by Hua Medicine Limited · Updated on 2026-05-06
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
H
Hua Medicine Limited
Lead Sponsor
T
TigerMed
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, how the body processes, and the effects of HMS1005 in adults with type 2 diabetes. This phase 1, randomized, double-blind, placebo-controlled study aims to understand how different doses of HMS1005 work and are tolerated by patients. The trial includes people with type 2 diabetes who meet specific health and treatment criteria. Participants will receive HMS1005 tablets or matching placebo in multiple ascending doses. The study includes several groups where six participants receive the active drug and two receive placebo at each dose level. The doses range from 123 mg to 492 mg, given as one or two tablets. The treatment and monitoring occur over about 19 days, including single-dose and steady-state phases. During the study, participants will undergo various evaluations including blood tests to measure glucose levels and drug concentration in plasma, physical exams, ECGs, vital signs, and laboratory tests. Researchers will track adverse events from enrollment through day 19 and measure pharmacokinetic parameters such as drug concentration over time. The overall participation time aligns with the dosing and monitoring schedule, ensuring safety and detailed assessment of the drug's effects.
CONDITIONS
Brief Title
A Phase 1, Multiple Ascending Dose Study to Evaluate HMS1005 in Participants With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 65 years
- Body mass index between 18 and 38.0 kg/m2
- Females not pregnant or breastfeeding; all females of childbearing potential and males agree to use contraception
- Diagnosis of type 2 diabetes by ADA 2025 criteria, either drug naïve, treated by diet and exercise, or stable on metformin or other antidiabetic medications
- Good general health except for type 2 diabetes, based on medical history, ECG, vital signs, labs, and physical exam
- Stable doses of antihypertensive and lipid-lowering medications for at least 30 days before screening
- 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
You will not qualify if you...
- Diagnosis of type 1 diabetes, maturity onset diabetes of the young, or diabetes due to pancreatic damage or other conditions
- Diabetic neuropathy, retinopathy, or nephropathy
- Recent acute diabetic complications within 6 months or chronic metabolic acidosis
- Severe hypoglycemia or recurrent hypoglycemia episodes within 3 to 6 months prior to dosing
- Hypoglycemia unawareness or asymptomatic hypoglycemia
- Significant liver disease within 1 year prior to screening
- Significant kidney disease (except mild to moderate chronic kidney disease)
- Significant cardiovascular diseases within 1 year prior to screening
- Significant central nervous system or psychiatric diseases within 1 year prior to screening
- Significant gastric emptying issues or history of gastric bypass surgery
- Unstable or significant disorders of other organ systems
- Known or active cancers except some skin cancers
- Recent hospital admission or major surgery within 90 days
- Significant allergies or hypersensitivity
- Low fasting C peptide (< 0.81 ng/mL)
- Elevated liver enzymes or bilirubin beyond specified limits
- Uncontrolled high triglycerides (> 500 mg/dL)
- Low kidney function (eGFR ≤ 45 mL/min/1.73 m2)
- Low hemoglobin levels
- Prolonged QT interval on ECG
- Positive tests for hepatitis B, hepatitis C, HIV
- Positive pregnancy test
- Use of insulin, sulfonylureas, GLP-1 agonists, DPP-4 inhibitors, SGLT2 inhibitors, or glinides
- Recent use of certain enzyme inducers or inhibitors
- Participation in another investigational drug study within 30 days
- Positive alcohol or drug screen at screening
- Current drug or alcohol abuse
- Recent consumption of alcohol, caffeine, grapefruit, or related products before check-in
- Use of tobacco or nicotine products within 1 month
- Recent blood donation or receipt
- Poor vein access
- Any condition judged by the investigator to prevent participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 19 days
Participants receive multiple ascending doses of HMS1005 or matching placebo to evaluate safety, tolerability, and pharmacokinetics.
Several visits including dosing and assessments from Day 1 to Day 19
Trial Site Locations
Total: 1 location
1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33172
Actively Recruiting
Research Team
J
Jesus Olivia
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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