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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT07076459
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male or female between the ages of 18 and 50 years, inclusive.
2. At least 50.0 kg for male subjects, 45.0 kg for female subjects, with a Body Mass Index (BMI) between 19.0-26.0 kg/m2, inclusive (BMI = weight/height2).
3. Prior to screening, during the trial, and for 90 days after the last administration, subjects (including male subjects) must not have plans to conceive and must voluntarily adopt effective contraceptive measures.
4. Subjects who could understand the nature, significance, potential benefits, inconvenience, and potential risks of the study, understand the procedures and methods, be willing to complete the trial strictly following the protocol, and voluntarily sign the informed consent.
Exclusion Criteria:
1. Subjects with history of drug or food allergies.
2. Subjects with a history of diseases related to the circulatory, endocrine, nervous, digestive, respiratory, hematolymphatic, immune, mental, skin, bone, muscle, urogenital, mucosal, and metabolic systems.
3. Use of any medication within 14 days prior to dosing.
4. Subjects who have taken any clinical investigational products or participated in the clinical research of medical devices within 90 days before the trial, or plan to participate in other clinical trials during the study.
5. Subjects who have donated blood or experienced blood loss greater than 300 mL, or have received a blood transfusion or used blood products within 90 days prior to screening.
6. Subjects who take more than 5 cigarettes per day on average within 90 days prior to the study or do not agree to prohibit smoking during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07076459
Study Brief:
Protocol Section:
NCT07076459