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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT05718518
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female subjects aged 18-60 years (including boundary values)
* If a woman has no planned pregnancy within 6 months after signing the informed consent, and is willing to use effective contraception (e.g. condom, uterine cap, non-hormonal intrauterine device \[IUD\]) for at least 3 months from the first administration of the study intervention to the last administration of the study intervention; Or not fertile (e.g. surgical sterilization \[bilateral oophorectomy, tubal ligation, or hysterectomy\] or natural sterilization \[continuous \> 12 months without menstruation\])
* If male, agree to use effective contraception throughout the study intervention and for at least 3 months after the last dose of the study intervention, and do not donate sperm.
* General good health based on history, physical examination (screening and check-in assessment), vital signs and other screening assessments.
* Able to understand the research content, comply with the research protocol, and voluntarily sign the informed consent.
Exclusion Criteria:
* Pregnant and lactating women.
* Patients with acute or chronic diseases, including but not limited to cardiovascular, digestive, respiratory, urinary, nervous, endocrine, immune, musculoskeletal, and skin conditions, were judged by the investigator.
* Any previous or existing hematological disorders or disorders, major liver disease, family history of bleeding/platelet disease.
* Previous or existing cancer (other than basal cell carcinoma or squamous cell carcinoma of the skin), or hygrosis.
* Have an autoimmune disease, immunosuppression, or any form of immune deficiency.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05718518
Study Brief:
Protocol Section:
NCT05718518