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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT02346760
Eligibility Criteria:
Inclusion Criteria:
* With age between 20 and 55 years.
* With no clinically relevant abnormalities in vital signs, and clinical laboratory tests at screening visit judged by investigator.
* Body weight: \<85 kg.
* Subject has signed the written informed consent form.
Exclusion Criteria:
* With significant active infection (acute or chronic) within 28 days prior to the screening visit.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases, or clinical findings within 3 months prior to the screening visit.
* Positive serology for HIV antibody, HCV antibody or HBV surface antigen.
* Female subjects who are breastfeeding, pregnant, and planning to become pregnant during the study period.
* The clinical investigator considers that the subject is not in the condition to participate in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT02346760
Study Brief:
Protocol Section:
NCT02346760