Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT05347758
Eligibility Criteria:
Inclusion Criteria:
1. Must be 18 to 55 years of age (inclusive) healthy male or female of nonchildbearing potential;
2. Body weight of at least 50 kg for male, and 45 kg for female; and Body Mass Index (BMI) within the range of 19 to 28 kg/m2 (inclusive);
3. Subjects (including partners) of childbearing potential are willing to use protocol specified effective methods of contraception from screening to at least 6 months after the final dose of study drug;
4. Able and willing to provide written informed consent and to comply with the study protocol;
5. Physical examination, vital signs are normal or are judged not clinically significant by the investigator;
Exclusion Criteria:
1. Participants with any abnormal results and judged clinically significant by the investigator;
2. HbA1c ≥6.2%, fasting blood-glucose ≤3.9mmol/L (70mg/dL) or ≥6.1mmol/L(110mg/dL) at screening ;
3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN; total bilirubin ≥1.5 x ULN at screening;
4. Abnormal ECG that is clinically significant, or QTcF \>450 msec;
5. Positive test result of any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis, or human immunodeficiency virus (HIV) antibody;
6. Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years;
7. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, history of pancreatitis or symptomatic gallbladder disease;
8. History of gastric emptying anomalies (gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcer) ;
9. Subject with major medical history of heart, liver, kidney, endocrine, digestive, blood, respiratory and genitourinary system or existing diseases of the above systems;
10. Use any prescription drugs, non-prescription drugs, food supplements, vitamins and Chinese herbal medicines within 2 weeks before administration;
11. Subject who received bariatric surgery or procedures, or use of weight-reducing drugs within 3 months prior to administration, or body weight change of more than ±10% within 3 months prior to administration;
12. Use any drugs that may affect glucose metabolism were used within 1 month before administration.
13. Suspected allergy to any ingredient in the study drug;
14. Participation in clinical trials of any drug or medical device within 3 months before screening;
15. History of regular alcohol consumption exceeding 14 drinks per week within 6 months before screening;
16. More than 5 cigarettes per day or cigarettes within 3 months before screening;
17. Subjects who consume alcoholic beverages, Seville oranges, grapefruit or juices, or products containing caffeine or xanthine (such as coffee, tea, cola drinks and chocolate) from 2 days before the start of study treatment;
18. Strenuous exercise in 48 hours before treatment;
19. Subjects with a history of drug abuse, drug dependence, or a positive drugs of abuse test, or a positive alcohol breath test before study drug administration;
20. Donation or loss of blood of ≥ 200 mL within 1 month or of ≥ 400 mL within 3 months prior to the first dose of study drug;
21. Subjects can't tolerate venipuncture;
22. Subjects have special dietary requirements and cannot comply with the unified diet;
23. Other conditions judged by the investigator to be not suitable to participate in the trial;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05347758
Study Brief:
Protocol Section:
NCT05347758