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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT06548932
Eligibility Criteria:
Inclusion Criteria:
* 1\. Voluntarily participated in the study and signed the informed consent form (ICF);
* 2\. Chinese healthy male adult subjects, aged 18-45 years old (both inclusive) at the time of signing the ICF;
* 3.Body mass index \[BMI= weight (kg)/height (m) 2\] at screening between 19.0 and 24.0 kg/m2, inclusive, a body weight ≥50 kg；
Exclusion Criteria:
* 1\. Abnormalities assessed by the investigator to be clinically significant while screening: vital signs, physical examination, laboratory examination, anterior and lateral chest X-ray and 12-lead ECG;
* 2\. Known severe allergy (such as allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, and allergy requiring glucocorticoid treatment) or known history of allergy to the drug ingredients used in this study;
* 3\. Participants who have smoked more than 5 cigarettes per day within 3 months before screening, smoked within 48 h before using the investigational drug, or impossibly stopped using any tobacco products during the test;
* 4.History of drug abuse or drug abuse before screening, or positive results in alcohol testing and urine drug screening (morphine, methamphetamine, methadone, phencycldine piperidine, tetrahydrocannabinol acid, cocaine) while screening;
* 5\. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06548932
Study Brief:
Protocol Section:
NCT06548932