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:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT06548906
Eligibility Criteria:
Inclusion Criteria:
* 1\. Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
* 2\. A Male adult subjects aged 18-55 years old.
* 3\. Body mass index (BMI) between 19.0-24.0 kg/m2
Exclusion Criteria:
* 1\. Known or suspected hypersensitivity to investigational medical product(s) or related products.
* 2\. Participation in a clinical study of another study drug within 3 months prior to randomization.
* 3\. Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.
* 4\. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening
* 5\. More than 14 units of alcohol per week within 3 months prior to randomization
* 6\. Smoking more than 5 cigarettes per day within 3 months prior to randomization
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06548906
Study Brief:
Protocol Section:
NCT06548906