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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT04963959
Eligibility Criteria:
Inclusion Criteria:
1. Healthy volunteers who signed informed consent form
2. Age ≥ 18 years and ≤ 40 years, male or female, Han nationality.
3. Weight: male ≥ 50 kg, female ≥ 45 kg; 18.5 ≤ BMI ≤ 30.
4. Temperature: 36.3-37.2℃ (Forehead temperature).
Exclusion Criteria:
1. Those with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders, neurological diseases, mental illnesses and those with a family history;
2. Those with known chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
3. Those with known allergic diseases or recurrent allergies;
4. Those with known malignant tumors or health-affecting benign tumors;
5. Two or more physical examination results of blood pressure have shown (except for white coat hypertension): systolic blood pressure \< 90 or ≥140mmHg, or diastolic blood pressure \< 60 or ≥ 90 mmHg, or pulse pressure \< 30 mmHg, heart rate: \< 60 beats/min or \>100 beats/min;
6. Laboratory tests: hemoglobin is abnormal and has clinical significant; liver and kidney function are higher than the normal upper limit and have clinical significance; 12-lead ECG is abnormal and has clinical significance, or abdominal ultrasound is abnormal and has clinical significance, or chest X-ray is abnormal and has clinical significance; abnormal coagulation function; increased CRP;
7. Those with active or latent hepatitis B or active hepatitis C, or Treponema pallidum antibody, or human immunodeficiency virus antibody, or anti-EBV IgM antibody, or anti-CMV IgM antibody, or COVID-19 DNA ;
8. Recipients of allogeneic tissue and organ or hematopoietic stem cell transplants;
9. Those who have undergone resection of vital internal organs such as stomach, kidney, spleen and lung;
10. Those who have undergone minor surgery within last 3 months, such as appendectomy and ophthalmic surgery; those who have undergone major surgery within 1 year, such as surgical treatment for gynecological benign tumors or superficial benign tumors;
11. Women who are pregnant, or have an abortion within last 6 months or gave childbirth within 1 year;
12. Those whose upper respiratory tract infection has recovered for less than 1 week, or pneumonia has recovered for less than 3 months;
13. Those whose acute pyelonephritis has recovered for less than 3 months, or those with acute exacerbation of urinary calculi;
14. Those who have been injured or wound-contaminated by equipment contaminated by blood or tissue fluids, or who have got a tattoo for less than 1 year;
15. Those who have received whole blood and blood component transfusion within 1 year;
16. Those who have received the last dose of live attenuated vaccines within 2 weeks, or have received the last dose of rubella live vaccine within 4 weeks;
17. Those who have received the last dose of rabies vaccines after being bitten by an animal within 1 year;
18. Those who have received the last dose of antitoxin or immune serum injection within 4 weeks, or those who have received the last dose of hepatitis B human immunoglobulin injection within 1 year;
19. Those who have participated in clinical trials within 3 months, or try to participate in other intervention trials during the study.
20. Those who are considered by the investigator as unsuitable for participating in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04963959
Study Brief:
Protocol Section:
NCT04963959