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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT07300202
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male or female, aged 18 to 60 years.
2. No clinically significant abnormalities in hematology, biochemistry, electrocardiogram (ECG), or vital signs as assessed by the investigator.
3. Willing to voluntarily participate in the study by signing the informed consent form.
4. Able to comply with study procedures and treatment as assessed by the investigator.
Exclusion Criteria:
1. History of allergy to herbal-derived drugs similar to the investigational product or any excipient.
2. Current or prior participation in another clinical trial involving an investigational product within the past 4 months.
3. Use of immunosuppressive drugs within 28 days prior to the first dose of Orialpha.
4. Active autoimmune disease or documented history of autoimmune disease within the past 2 years.
5. History of primary immunodeficiency.
6. Presence of any acute or chronic illness requiring treatment.
7. Inability to comply with study procedures or investigational product administration as assessed by the investigator.
8. Female subjects who are pregnant or breastfeeding, or male or female subjects of reproductive potential not using effective contraception.
9. Any condition which, in the opinion of the investigator, would interfere with the evaluation of the investigational treatment, patient safety, or interpretation of study results
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07300202
Study Brief:
Protocol Section:
NCT07300202