Type 2 Diabetes Mellitus
Conditions
Interventions
Single Ascending Dose-60mg:60mg VCT220 and placebo
Single Ascending Dose-200mg:120mg VCT220 and placebo
Single Ascending Dose-30mg:30mg VCT220 and placebo
Single Ascending Dose-10mg:10mg VCT220 and placebo
Single Ascending Dose-300mg:120mg VCT220 and placebo
Single Ascending Dose-120mg:120mg VCT220 and placebo
Single Ascending Dose-pilot study:10mg VCT220
Food effect study:fasten-food VCT220-120mg
food-fasten VCT220-120mg
Sponsors
West China Second University Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.The subject fully understands the trial's purpose, nature, procedures, and potential adverse reactions, voluntarily participates as a subject, and signs the informed consent form before initiation of any study-related procedures; 2.Healthy male and female subjects aged 18 to 45 years (inclusive), with appropriate gender distribution; 3.Body weight >=50.0 kg for males and >=45.0 kg for females; body mass index (BMI) within 19.0–26.0 kg/m^2 (inclusive); 4.Vital signs, physical examination, clinical laboratory tests (complete blood count, urinalysis, stool routine + occult blood, blood biochemistry, infectious disease screening, coagulation panel), 12-lead ECG, abdominal ultrasound, chest X-ray, and infectious disease screening show results within normal limits or with clinically non-significant abnormalities; 5.Subjects agree to use effective contraception throughout the trial and for 90 days post-trial, with no plans for pregnancy, sperm donation, or egg donation during this period; 6.Subjects capable of effective communication with investigators, able to understand, and willing to comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1.History of hypersensitivity or known allergy to VCT220, structurally related compounds, or excipients (e.g., lactose, mannitol, croscarmellose sodium, sodium stearyl fumarate); or atopic/allergic disorders (e.g., asthma, urticaria, eczematous dermatitis) (Medical history); 2.Acute illness within 2 weeks prior to screening or investigational product administration (Medical history); 3.Major surgery affecting drug ADME (absorption, distribution, metabolism, excretion) within 6 months prior to trial, or planned surgery during study (Medical history); 4.Clinically significant chronic diseases (e.g., respiratory, gastrointestinal, cardiovascular, renal, hematologic, endocrine, immune disorders) (Medical history); 5.Vaccination within 4 weeks prior to trial (Medical history); 6.Participation in other clinical trials involving investigational drugs within 3 months prior to trial (Medical history); 7.Clinically relevant ECG abnormalities: - PR interval >250 ms - QRS complex >120 ms - QTcF >450 ms (females) or >430 ms (males) (ECG); 8.Use of any prescription/non-prescription drugs, herbal products, or supplements within 2 weeks prior to dosing (Medical history); 9.Blood donation/loss: - =400 mL total blood loss within 6 months (excluding menstrual bleeding) - Any donation within 3 months (Medical history); 10.Alcohol use: - History of alcoholism (>40 g/week ethanol within past year) - Positive alcohol breath test (>0.0 mg/100mL) - Inability to abstain during trial (History + Breath test); 11.Tobacco use: - >5 cigarettes/day within 3 months prior to trial - Inability to abstain from tobacco products during trial (Medical history); 12.Substance abuse: - Non-medical use of controlled substances within 3 months - Positive urine drug screen (morphine, methamphetamine, ketamine, MDMA, THC) (History + UDS); 13.Intolerance to venipuncture or history of needle/phobia syncope (Medical history); 14.Inability to comply with standardized diet (Medical history); 15.Investigator’s judgment of ineligibility (e.g., low enrollment likelihood, poor compliance risk); 16.Oral contraceptive use within 30 days prior to trial (Medical history); 17.Long-acting estrogen/progestin therapy (injections, implants, hormonal IUDs) within 6 months (Medical history); 18.Unprotected intercourse within 14 days prior to trial (with pregnancy risk) (Medical history); 19.Positive serum ß-hCG pregnancy test (Laboratory); 20.Lactation (Medical history);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK Parameters; | — |
Countries
China
Contacts
Public ContactYu Qin
West China Second University Hospital of Sichuan University
Outcome results
None listed