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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT06254235
Eligibility Criteria:
Inclusion Criteria:
* BMI 19-28 kg/m\^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female
* In good physical condition (without any history of disease or clinically relevantly abnormal vital sign or examination
* Agreed to use adequate contraception and did not plan for pregnancy from screening period throughout 6 months after study completion
* Fully understood and voluntarily signed the informed consent form
* With high compliance
Exclusion Criteria:
* With allergic disease or allergic to any component of the study drugs or more than two kinds of other drug, food, or beverage
* Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test
* With gastrointestinal disease
* Had drug addiction within 5 years or used narcotics within 6 months before screening or positive in drug of abuse test
* With alcohol consumption \> 2 units/d within 6 months before screening
* With cigarette consumption \> 5/d within 3 months before screening
* Donated or lost blood \> 400 mL within 3 months before screening
* Hospitalized or received surgery within 3 months before screening
* Received study drug of other clinical trial within 3 months before screening
* Received prescription drug within 14d before dosing
* Received over-the-counter drug or herb within 48h before dosing
* Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine within 72h before dosing
* Consumed alcohol within 48h before dosing or positive for breath alcohol test
* Cannot consume standard meal
* Intolerable to venipuncture
* Cannot receive intramuscular injection in the glute
* With vitamin B12 deficiency
* Had acute minor disease (common cold, diarrhea, etc.) from screening to dosing
* For pregnancy-capable female, breastfeeding or positive for pregnancy test at screening, or had unprotected sexual contact within 2 weeks before dosing
* Other reason judged by investigators
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06254235
Study Brief:
Protocol Section:
NCT06254235