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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT06816251
Eligibility Criteria:
Inclusion Criteria:
1. Age 18\~85 years old (including boundary value), male or female.
2. Body mass index \< 35 kg/m2.
3. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
4. Female subjects of childbearing potential must have a serum pregnancy test prior to the first dose with a negative result and must be non-lactating during the study.
5. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time of signing the informed consent form until 3 months after the last dose of the trial drug, and comply with the relevant contraceptive requirements.
Exclusion Criteria:
1. Known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy.
2. Paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening.
3. History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
4. Those who have participated in the clinical trial of any drug or medical device within 3 months before screening.
5. Other conditions that the investigator considers the subject to be unsuitable for participating in this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06816251
Study Brief:
Protocol Section:
NCT06816251