This is a Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HW243040 in healthy participants. The study consists of two parts: Part A (Single Ascending Dose, SAD) and food effect study, and Part B (Multiple Ascending Dose, MAD). A total of approximately 98 healthy participants will be enrolled.
Signed informed consent form prior to any study-related procedures, with full understanding of the study content, procedures, and potential adverse reactions, and ability to complete the study as per protocol requirements.
Healthy male or female, aged ≥ 18 and ≤ 55 years on the day of signing the informed consent form.
Body weight: males ≥ 50 kg, females ≥ 45 kg; body mass index (BMI) between 19 and 26 kg/m² inclusive (BMI = weight (kg) / height² (m²)).
Vital signs, physical examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, and thyroid function), and 12-lead electrocardiogram (ECG) findings are normal or clinically insignificant at screening and baseline.
Current or previous history of any clinically significant disease involving the urinary, cardiovascular, endocrine, neurological, digestive, respiratory, hematopoietic, immune, psychiatric, or metabolic systems, or any other condition that, in the investigator's judgment, may interfere with the study results, such as intestinal diseases (including irritable bowel syndrome) and urinary tract infections.
History of malignancy (except for cancers that have been cured or in remission for ≥ 5 years, radically resected basal cell or squamous cell skin carcinoma, in situ cervical carcinoma, and resected colon polyps).
Any condition or disease that, in the investigator's judgment, may affect the absorption, metabolism, and/or excretion of the study drug.
Severe infection, severe trauma, or major surgery within 3 months prior to screening or baseline, or planned surgery during the study period.
Sequential
HW243040
DrugHW243040 tablets, 50mg and 200mg规格, administered orally. Doses range from 50mg to 1200mg as a single dose in Part A, or 150mg to 600mg twice daily for 5 days in Part B. Administered with 240mL water under fasting or fed (high-fat, high-calorie meal) conditions as specified per arm.
HW243040 Matching Placebo
DrugHW243040 matching placebo tablets, 50mg and 200mg规格, identical in appearance to HW243040 active tablets. Administered orally with 240mL water under the same conditions as the corresponding active dose arm.
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Treatment groupsSee each treatment group below.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants with TEAEs, including serious adverse events (SAEs), assessed by CTCAE v5.0.
Number of Participants with Clinically Significant Vital Signs Changes
Number of Participants with Clinically Significant Laboratory Abnormalities
Number of Participants with Clinically Significant 12-lead ECG Abnormalities
Maximum Observed Plasma Concentration (Cmax) Following Single Ascending Dose Administration
Cmax of HW243040 in plasma following single ascending dose administration, measured by validated LC-MS/MS method.
Time to Maximum Observed Plasma Concentration (Tmax) of HW243040 Following Single Ascending Dose Administration
Tmax of HW243040 in plasma following single ascending dose administration, determined directly from concentration-time data.
Apparent Terminal Elimination Half-life (t1/2) of HW243040 Following Single Ascending Dose Administration
Terminal elimination half-life of HW243040 in plasma following single ascending dose administration, calculated as ln(2)/λz.
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of HW243040 Following Single Ascending Dose Administration
AUC0-t of HW243040 in plasma following single ascending dose administration, calculated using the linear-up/log-down trapezoidal method. Unit: h\*ng/mL.
Change from Baseline in QTcF Interval (ΔQTcF and ΔΔQTcF)
Change from baseline in Fridericia-corrected QT interval (ΔQTcF) and placebo-corrected change from baseline (ΔΔQTcF).
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