Safety, Tolerability and Pharmacokinetic Study of HRS-8829

Korábbi kezelés

• Those who have used any drugs that inhibit or induce liver enzymes within one month before administration
• Those who have used or are currently using any medication within two weeks prior to administration
• Those who have received a vaccine within one month prior to screening (except for the influenza vaccine) or plan to receive a vaccine during the trial period
• Those who have undergone major surgical operations within the six months prior to screening
• Blood donation or loss of more than 400 mL within 3 months prior to screening
• Participate in the clinical trial of the drug as a subject and take the trial drug
• Consumed more than 14 units of alcohol per week on average within the 3 months prior to screening

Más betegség

• Have any history of allergies
• Have had or are currently suffering from diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, musculoskeletal system and nervous system, etc
• Those who test positive for any one of hepatitis B surface antigen, hepatitis C antibody, syphilis specific antibody or human immunodeficiency virus antigen-antibody during the screening period
• Those with a history of drug abuse

Egyéb

• The electrocardiogram at lead 12 was abnormal and was judged by the researcher as unsuitable to participate in this study
• Those whose screening period examination results are judged by the research doctor as abnormal and of clinical significance
• Those who smoked more than 5 cigarettes or an equivalent amount of tobacco per day
• Those who consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice and/or caffeinated beverages daily
• Consume special food within 48 hours before administration
• Those who cannot tolerate venipuncture
• Those who have special dietary requirements
• The researchers believe that the subjects have any other factors that make them unsuitable for participating in this trial

• Male and female subjects aged 18 to 55 years old
• The weight of female subjects was ≥45 kg, that of male subjects was ≥50 kg, and the body mass index (BMI) was within the range of 19.0-28.0 kg/m2
• The female subjects were not in the pregnancy or lactation period, and the pregnancy examination results before the test were negative; Male or female subjects agreed to take the investigator-approved effective contraceptive measures during the trial as required by the investigator.
• Voluntarily participate in this clinical trial