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:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-24 @ 12:01 PM
NCT ID:
NCT06919861
Eligibility Criteria:
Inclusion Criteria:
* Male aged between 18 and 45.
* Weight between 50 kg and 70 kg, BMI between 18 and 27 at the time of screening.
* Subjects of reproductive age must approve the use of effective contraception (such as oral contraceptives, intrauterine or implantable, intrauterine placement, physical methods, etc.) from screening until 6 months after the last dose.
* Signed an informed consent form to participate in the study.
Exclusion Criteria:
Subjects who meet at least one of the following criteria will be excluded from the study:
* Use EPO (erythropoietin), darbepoetin, or another source of EPO protein, immunoglobulin, within 3 months before screening.
* History of severe allergic reactions or anaphylactic reactions to biological products.
* There are any clinically significant diseases such as high blood pressure, other cardiovascular diseases, psychiatry, cancer, acute and chronic respiration, diabetes, chronic inflammation (such as rheumatoid arthritis, lupus erythematosus, etc.), or autoimmune diseases.
* Having a history of red blood cell diseases such as thalassemia, sickle cell...
* Those who bled over 400mL or donated blood within 8 weeks of the scheduled first dose.
* People with screening results:
* Hemoglobin level below 12 g/dL or above 17 g/dL;
* Vitamin B12 level below 200 pg/mL;
* Ferritin level below 21.8 ng/mL;
* Transferrin level below 190 mg/dL;
* Albumin level below 3.5 g/dL or more than 4.8 g/dL;
* Reticulocyte, erythrocytes, platelets, or serum potassium level over the normal range
* Positive on the HIV antibody, HBsAg, HCV(Hepatitis C Virus) antibody tests.
* Those whose vital signs are measured in the sitting position after resting for over 3 minutes meet more than one of the following: Systolic BP below 90mmHg or over 160mmHg, Diastolic BP below 50mmHg or over 100mmHg, Pulse rate over 100.
* History of drug abuse, or tested positive in the urine drug screening
* Those who have a drinking problem or are unable to abstain from alcohol during the study period.
* Those who have smoked over 10 cigarettes daily on average for the last 3 months or who can't renounce smoking during the trial period.
* People who have ingested caffeine-containing food within 3 days of the scheduled first dose or who can't abstain from the during the trial period.
* Those with peculiar eating habits or who can't have meals provided by the study center.
* Those who participated in other clinical trials and were administered other study drugs within 1 year of the scheduled first dose.
* Those who are preparing for pregnancy or who do not agree with contraception during the trial period
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06919861
Study Brief:
Protocol Section:
NCT06919861