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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT03591133
Eligibility Criteria:
Inclusion Criteria:
1. Subjects with a body-mass index (BMI) of 18.5 to less than 25.0 at the time of the screening tests
2. Subjects judged by the principal investigator or a subinvestigator to be appropriate for participation in the study based on the results of the screening tests and the tests conducted prior to the investigational drug treatment
Exclusion Criteria:
1. Subjects who meet any of the following criteria in the screening tests or the tests conducted on Day -1 and prior to the investigational drug treatment
* Red blood cell count: ≥ 535 × 10\^4 /μL
* Hemoglobin: ≥ 16.2 g/dL
* Hematocrit: ≥ 47.5%
* Reticulocyte ratio: Outside of the reference value range
2. Subjects who meet any of the following criteria in the screening tests
* Serum EPO concentration: Outside of the reference value range
* Ferritin: 30 ng/mL or less, or ≥ 262 ng/mL
3. Subjects who meet any of the following criteria in the vital signs in the screening tests and the tests conducted prior to the investigational drug treatment
* Blood pressure: Systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ 90 mmHg or more
* Pulse rate: \< 40 bpm, or ≥ 100 bpm
* Body temperature: ≥ 37.5°C
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
39 Years
Study:
NCT03591133
Study Brief:
Protocol Section:
NCT03591133