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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT04317833
Eligibility Criteria:
Inclusion Criteria:
* Body weight≥50 for male or ≥45 for female, and BMI between 19.0-26.0 kg/m2
* Good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead ECG, clinical laboratory tests and B-type ultrasound test.
* Participants of reproductive potential must agree to utilize reliable methods of contraception from screening to 6 months after the last administration of the study intervention. No plan for sperm (or egg) donation or pregnancy.
* Understand and sign the informed consent.
* Ability to understand and follow study-related instruction
Exclusion Criteria:
* A known allergy to any component of the SSS17 formulation, or allergy history of two kinds of drugs or food
* Medical history or conditions of digestive system.
* Female volunteers who are pregnant, menstrual, lactating or menopause with hormone therapy.
* Eyes diseases, including diabetic retinopathy, age-related macular degeneration.
* Vascular anomalies.
* Drug, alcohol or nicotine addiction.
* Blood donation or bleeding (more than 200 ml). Experience of treatment with EPO or blood transfusion.
* Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance
* Abnormal results in test of TIBC, serum iron or ferritin
* Acute diseases before administration.
* Other situations that the researcher believes may affect validity judgment or are not suitable for participation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04317833
Study Brief:
Protocol Section:
NCT04317833