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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT04006860
Eligibility Criteria:
Inclusion Criteria:
* 1\. Healthy male subject,18-45 years of age.
2\. BMI between 19 and 26; Weight between 50 and 80 kg.
3\. Healthy medical examination ,various laboratory inspection indicators normal, or the abnormal signs have no clinical significance.
4\. Subjects (including their partners) who are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose.
5\. Sign the informed consent form before the study and fully understand the study content, process and possible adverse reactions.
Exclusion Criteria:
* 1\. Nervous system, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, musculoskeletal system, etc. are abnormal and have clinical significance as determined by investigator.
2\. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity.
3\. Addicted to smoking and drinking in 3 months before the trial.
4\. Hemorrhage over 200mL , receive blood transfusions or use blood products in 3 months before the trial.
5\. Other conditions not suitable for trial, by judgement of investigator.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04006860
Study Brief:
Protocol Section:
NCT04006860