A Trial of HRS-2261 in Healthy Subjects After Single and Multiple Oral Administration

Inclusion criteria

• Able and willing to provide a written informed consent.
• Age 18 to 55 years (inclusive).
• Weight of male subjects ≥50 kg, female ≥45kg, body mass index (BMI) 19-26 kg/m2 (inclusive).
• Medical examination (including physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound and chest radiography) normal or abnormal with no clinical significance.

Exclusion criteria

• Any clinically serious diseases such as circulatory, endocrine, nervous, digestive, respiratory, blood, immune, mental and metabolic abnormalities or any other diseases that investigator determines may interfere with the test results.
• Subjects with severe infection, severe trauma or major surgical operation within 3 months prior to screening; Subjects who plan to undergo surgery during the trial period and within two weeks after the trial.
• Treated with any drug that inhibits or induces drug metabolism in the liver within 1 month prior to administration.
• Subjects have any condition or medical condition that affects absorption, metabolism, and/or excretion of the study drug according to the investigator.
• Subjects enrolled in clinical trials of any drug or medical device within 3 months prior to screening, or within 5 half-lives of the drug before screening.
• Subjects who had a history of smoking in the previous 3 months (average daily smoking > 5 cigarettes), or who could not stop using any tobacco products during the test period.
• Subjects who consumed more than 15g of alcohol per day on average (15g of alcohol is equivalent to 450 mL beer, 150 mL wine or about 50mL low-alcohol white wine) or tested positive for alcohol during the 3 months prior to screening, or who could not abstain from alcohol during the test period.
• Subjects with a history of drug abuse, drug dependence or positive drug screening.
• Determined by the investigator to be unfit to participate in this clinical trial.