A Phase I Trial of QLS1410 in Healthy Chinese Adults and Participants With Mild Essential Hypertension

Exclusion Criteria

• •Part A \& Part B: Healthy Participants
• •Any medical condition/disease at screening deemed by the investigator to require exclusion, including but not limited to the nervous, psychiatric, cardiovascular, hematologic/lymphatic, immune, respiratory, digestive, urinary, metabolic and skeletal systems.
• •Dysphagia or any surgical condition/disease that may affect drug absorption, distribution, metabolism, or excretion, at screening.
• •Use of systemic corticosteroids within 3 months prior to screening.
• •Mean pulse/heart rate (HR) \>100 or \<50 bpm after ≥5 min of rest at screening (measured 3 times consecutively).
• •Any laboratory abnormalities that meet the test requirements should be noted during screening (if necessary, retest can be conducted at least one week apart):
• •Smoking \>5 cigarettes/day on average within 6 months before screening, or current use of e-cigarettes.
• •Alcohol consumption \>14 units/week (1 unit = 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine) within 6 months before screening, or has a positive breath alcohol test at screening.
• •Blood donation \>400 mL within 3 months or \>200 mL within 4 weeks before screening, or plan to donate blood during the study.
• •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.
• •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.
• •Pregnant/lactating females or positive pregnancy test at screening.
• •Inability to tolerate a high-fat meal (for Part B only).
• •Part C: Participants with Mild Essential Hypertension
• •Secondary hypertension.
• •Orthostatic tachycardia or hypotension at screening, or history of related symptoms (e.g., dizziness, weakness, blurred vision upon standing).
• •History of syncope.
• •Metabolic/cardiovascular disorders: 1) Diabetes (fasting glucose ≥7.0 mmol/L \[126 mg/dL\] or HbA1c ≥6.5%); 2) History of cardiovascular events (e.g., stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, heart failure hospitalization) or clinically significant valvular disease; 3) Personal/family history of long QT syndrome, torsades de pointes (TdP), arrhythmias, or sudden cardiac death; 4) Other conditions that may interfere with the study or increase risk, per investigator judgment.
• •Laboratory abnormalities (as defined in Part A/B, with repeat testing allowed).
• •Any other condition deemed unsuitable by the investigator.