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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07358858
Eligibility Criteria:
Inclusion Criteria:
1. Able to understand and willing to comply with all study visits, procedures, restrictions and provide the written informed consent form (ICF).
2. Males and females aged 18 to 55 years, inclusive.
3. Weight ≥ 50 kg for males and ≥ 45 kg for females, Body mass index (BMI) between 18 and 26 kg/m\^2, inclusive, at screening.
4. Has a mean seated office systolic blood pressure (SBP) 110\~139 mmHg (inclusive) and diastolic blood pressure (DBP) 70\~89 mmHg (inclusive) at screening and baseline; measured 3 times consecutively (1-2 min intervals).
5. QTcF (QT corrected using Fridericia's formula) \<450 ms for males and \<470 ms for females.
6. Participants (including partners) must agree to abstain from sperm/egg donation and pregnancy plans, and to use highly effective contraception, from signing the ICF until 3 months after receiving the last dose of investigational product.
Exclusion Criteria:
1. Any medical condition/disease at screening deemed by the investigator to require exclusion, including but not limited to the cardiovascular, respiratory, digestive, urinary, endocrine metabolic, skeletal, muscular, hematologic, immune, nervous system.
2. Dysphagia or any surgical condition/disease that may affect drug absorption, distribution, metabolism, or excretion, at screening.
3. Use of systemic corticosteroids within 3 months prior to screening.
4. Any clinically significant abnormal result of vital signs, physical examinations, laboratory tests, chest X-ray, and abdominal B-ultrasound, at screening.
5. Active viral hepatitis (B or C), TP, and HIV as demonstrated by positive serology at Screening.
6. Mean pulse \>100 or \<50 bpm after ≥5 min of rest at screening (measured 3 times consecutively).
7. Any of the following laboratory abnormalities at screening: ALT or AST \>1.5 x upper limit of normal (ULN); Total bilirubin \>1.5 x ULN (participants with Gilbert's syndrome may qualify if direct bilirubin ≤ULN); Creatinine \>ULN or eGFR \<90 mL/min/1.73 m²; Serum potassium \>ULN or sodium \<135 mmol/L.
8. Smoking \>5 cigarettes/day on average within 6 months before screening, or current use of e-cigarettes.
9. Alcohol consumption \>14 units/week (1 unit = 357 mL of 3.5% beer, 27 mL of 40% spirits, or 104 mL of 12% wine) within 6 months before screening, or has a positive breath alcohol test at screening.
10. Blood donation \>400 mL within 3 months or \>200 mL within 4 weeks before screening, or plan to donate blood during the study.
11. Use of strong CYP3A4 or CYP1A2 inhibitors within 7 days or 5 half-lives (whichever is longer) before screening. Use of strong CYP3A4 inducer within 14 days or 5 half-lives (whichever is longer) before screening.
12. Use of any prescription drugs, OTC drugs, traditional medicines, and dietary supplements within 2 weeks or 5 half-lives (whichever is longer) prior to randomization.
13. Pregnant/lactating females or positive pregnancy test at screening.
14. Inability to tolerate a high-fat meal.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07358858
Study Brief:
Protocol Section:
NCT07358858