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:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT05887895
Eligibility Criteria:
Inclusion Criteria:
1. Able and willing to provide a written informed consent;
2. Male or female aged 18-45 at screening (both inclusive);
3. Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator;
4. Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, body mass index (BMI) in 18.0\~26.0 kg/m2 (both inclusive);
5. During the screening phase oral glucose tolerance test (OGTT), intravenous fasting plasma glucose ≥3.9 mmol/L and \< 6.1 mmol/L; Glucose 2 hours after negative charge static pulse blood sugar \<7.8mmol/L； and normal or abnormal insulin levels have no clinical significance.
Exclusion Criteria:
1. A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug;
2. Have a history of hypertension;
3. Severe systemic infectious diseases within 1 month before screening;
4. Patients with a history of lower extremity deep vein thrombosis or high risk of lower extremity deep vein thrombosis;
5. Patients with serious diseases of the psychiatric, cardiovascular, respiratory, digestive, endocrine, blood, urogenital and other systems in the past, or existing diseases of the above systems, were judged by the researchers to be unfit to participate in this study;
6. Use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, and Chinese herbal medicine (regular vitamins are allowed) within 2 weeks before screening;
7. Presence of any abnormal and clinically significant laboratory tests.
8. ECG (12-lead electrocardiogram) showed abnormal and clinically significant.
9. Those who have participated in any drug clinical trials within 3 months or 5 half-life periods before screening (the elder shall prevail), who participated in clinical trials are defined as random, prior to screening.
10. Blood donation within 1 month before screening; Or patients with trauma or major surgical procedures who donated blood or lost blood ≥400 mL in the 3 months prior to screening.
11. Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (WOCBP) are reluctant to use appropriate contraception during the trial.
12. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05887895
Study Brief:
Protocol Section:
NCT05887895