A Clinical Study of HRS-5765 in Healthy Participants

Korábbi kezelés

• Severe infection, trauma, major surgery within 3 months before screening; Planned surgery during the trial.
• Blood donation/severe blood loss (≥ 400 mL) within 3 months, blood transfusion within 4 weeks before screening; Planned blood donation during the trial.
• History of drug abuse/dependence; positive urine drug test at screening. Participation in other clinical trials within 3 months before screening or planned.
• Participation during the trial; Within 5 half-lives of a prior drug (whichever is longer).
• Smoking history (≥ 5 cigarettes/day) within 4 weeks before screening; Inability to abstain from tobacco during the trial.

Más betegség

• A history or current severe diseases of multiple systems, or other diseases interfering with trial results.
• Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening.

Egyéb

• Special dietary requirements and inability to comply with the unified diet.
• Difficulty in swallowing/venous blood collection; Intolerance to intensive blood sampling.
• Other circumstances deemed unsuitable for trial participation by researcher.

• Healthy men and women aged 18 to 65 years old at informed consent signing.
• Male body weight ≥ 50 kg and < 90.0 kg, female ≥ 45 kg and < 90.0 kg; BMI 19 to 26 kg/m² at screening and baseline.
• Have no clinically significant abnormalities at screening and baseline.
• Fertile females and males with fertile female partners: effective contraception consent, and sustained until 1 week after the last dose (abstinence or highly effective contraception); no sperm/egg donation.