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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT05130567
Eligibility Criteria:
Inclusion Criteria:
* Subjects have no history of serious digestive system, central nervous system, cardiovascular system, kidney, respiratory system, metabolism and endocrine, skeletal and muscular system, blood system disease and cancer
* Subjects (including partners) are willing to take effective contraception measures during study and within 3 months after last dose
* Male and female healthy subjects aged 18 to 55 years old
* Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg
* Subjects able to understand and comply with study requirements
* Willing to sign the informed consent and fully understand the content, process and possible adverse reactions of the trial
Exclusion Criteria:
* Abnormal vital signs, physical examination or laboratory tests with clinical significance
* Abnormal ECG, chest X-ray, abdominal ultrasound or echocardiography with clinical significance
* Positive screening for viral hepatitis, HIV and syphilis
* Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug; or subjects who have consumed tea or alcohol-containing food product within 24hrs before administration the study drug
* Subjects who have a history of dysphagia or condition may affect drug absorption, distribution, metabolism and excretion
* Female subjects are breastfeeding or pregnant
* Subjects who have a history of drug/alcohol/tobacco abuse
* Subjects who have had a blood donation or massive blood loss within three months before screening; or had major surgery within six months before screening
* Subjects who have participated in other clinical trial within three months before screening
* Subjects have special dietary requirements or cannot tolerate a standard meal
* Subjects who are not suitable for this trial based on the assessment of investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05130567
Study Brief:
Protocol Section:
NCT05130567