A Phase I Clinical Study Comparing the Relative Bioavailability, Safety and Tolerability of the First-generation and Second-generation Formulations of HRS9531 Tablets and Exploring the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Escalation of the Second-generation Formulation
This study aims to compare the relative bioavailability, safety and tolerability of the first-generation and second-generation formulations of HRS9531 tablets, as well as to explore the safety, tolerability and pharmacokinetic characteristics of the second-generation formulation in terms of single-dose escalation.
• Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
• Male subjects aged 18-55 years on the date of signing informed consent (inclusive);
• Body weight ≥65 kg, body mass index (BMI) within the range of 24.0-35.0 kg/m2 (inclusive);
• The weight change within the previous 3 months should not exceed 5 kilograms.
• Based on the patient's past medical history, physical examination, vital signs, laboratory tests and electrocardiogram (ECG) examinations, the researchers determined that the overall overweight and obese subjects were included.