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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT07021157
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male and female participants aged 18 to 45 years (inclusive).
2. Male participants: Body weight ≥50 kg; Female participants: Body weight ≥45 kg; Body mass index (BMI) between 19.0 and 26 kg/m².
3. Participants must have no plans for conception during the trial and for 3 months after the last dose, and must voluntarily use effective contraception with no plans for sperm or egg donation .
4. Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.
Exclusion Criteria:
1. Have a specific history of allergies or have an allergic constitution；
2. Have a history of chronic diseases or severe diseases in the cardiovascular, liver, kidney, biliary tract, respiratory, blood and lymphatic, endocrine, immune, mental, neuromuscular, gastrointestinal systems, etc.
3. Developed acute diseases from 2 weeks before screening to before randomization ;
4. Patients with previous or current hypotension or insufficient blood volume, intracranial hypertension or cerebral hemorrhage, or those with ocular diseases (such as angle-closure glaucoma), who are not suitable for inclusion after assessment by the researcher;
5. Those with clinical significance hypokalemia, hyperkalemia, hypomagnesemia, hypermagnesemia, hypocalcemia, and hypercalcemia;
6. Those who have used any drugs or health supplements from 2 weeks before screening to randomization ;
7. Any drugs that may interact with this product have been used from 30 days before screening to randomization, such as CYP450 inhibitors or inducers ;
8. Those who have undergone major surgical operations from 6 months before screening , or who plan to undergo surgery during the study period, or who have undergone surgeries as judged by the investigator to affect drug absorption, distribution, metabolism, and excretion;
9. Those who have received live attenuated vaccine inoculation from 2 weeks before screening to randomization or those who need to receive live attenuated vaccine inoculation during the trial;
10. Those who had a history of alcohol abuse within one year before screening；
11. Those who smoked more than 5 cigarettes per day on average within 3 months before screening and before randomization, or were unable to stop using any tobacco products during the trial period;
12. Those who cannot tolerate venipuncture/indwelling needles or have a history of fainting from needles or blood ;
13. Other researchers determined that the subjects were not suitable to participate.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07021157
Study Brief:
Protocol Section:
NCT07021157