A Food Effect Study of QLS1410 in Healthy Chinese Adults

Korábbi kezelés

• Use of systemic corticosteroids within 3 months prior to screening.
• Smoking >5 cigarettes/day on average within 6 months before screening, or current use of e-cigarettes.
• 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.
• 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.

Más betegség

• 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.
• Dysphagia or any surgical condition/disease that may affect drug absorption, distribution, metabolism, or excretion, at screening.
• Active viral hepatitis (B or C), TP, and HIV as demonstrated by positive serology at Screening.

Laborértékek

• Any clinically significant abnormal result of vital signs, physical examinations, laboratory tests, chest X-ray, and abdominal B-ultrasound, at screening.
• 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.

Egyéb

• Mean pulse >100 or <50 bpm after ≥5 min of rest at screening (measured 3 times consecutively).
• Pregnant/lactating females or positive pregnancy test at screening.
• Inability to tolerate a high-fat meal.

• Able to understand and willing to comply with all study visits, procedures, restrictions and provide the written informed consent form (ICF).
• Males and females aged 18 to 55 years, inclusive.
• Weight ≥ 50 kg for males and ≥ 45 kg for females, Body mass index (BMI) between 18 and 26 kg/m\^2, inclusive, at screening.
• 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).
• QTcF (QT corrected using Fridericia's formula) <450 ms for males and <470 ms for females.
• 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.