a study to evaluate the safety, tolerability, and pharmacokinetics of oral hrs5685 in healthy subjects

Conditions: Human Immunodeficiency Virus-1 (HIV-1) Infection

Summary: this is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single ascending dose (part a) and multiple ascending dose (part b) of hrs5685 tablet in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide written informed consent and to comply with the study protocol; 2. must be 18 to 45 years of age (inclusive); 3. body weight of at least 50 kg for male, and 45 kg for female; and body mass index (bmi) within the range of 18 to 28 kg/m2 (inclusive); 4. physical examination, vital signs, laboratory tests, 12-lead ecg, egfr (ckd-epi formula), abdominal ultrasound and chest radiograph are normal or are judged not clinically significant by the investigator; 5. subjects (including partners) of childbearing potential are willing to useprotocol specified effective methods of contraception from screening to at least 8 months (for female) or 6 months (for male) after the final dose of study drug; exclusion criteria: 1. history or presence of any clinically significant cardiovascular, endocrine, neurological, gastrointestinal, respiratory, hematological, immunological, psychiatric, metabolic disorders or any diseases that may interfere with the study results; 2. subjects with severe infections, severe trauma or major surgical operation within 3 months before drug administration; or subjects plan to undergo surgery during the trial and within two weeks after the end of trial; 3. abnormal ecg that is clinically significant, or qtcf\ 450 msec for men and \>460 msec for women; 4. positive test result of any of the following at screening: hepatitis b surface antigen (hbsag), hepatitis c antibody, syphilis, or human immunodeficiency virus (hiv) antibody; 5. suspected allergy to any ingredient in the study drug; 6. use of any drug that inhibits or induces hepatic metabolism within 1 month prior to the first dose of study drug; 7. any condition or disease that affects the absorption, metabolism, and/or excretion of the study drug as judged by the investigator; 8. use of any prescription or over-the-counter medication, including herbal medications within 1 month prior to the first dose of study drug; 9. participation in clinical trials of any drug or medical device (except for screening failures) within 3 months before screening, or within 5 half-lives of the drug at screening (whichever is longer); 10. receiving vaccine(s) within 1 month prior to the first dose of study drug; 11. donation or loss of blood of ≥ 200 ml within 1 month or of ≥ 400 ml within 3 months prior to the first dose of study drug; or receiving blood transfusion within 8 weeks prior to the first dose of study drug; or have difficulty in venous blood collection, or whose physical condition cannot withstand intensive blood sampling; 12. an average daily smoking of ≥ 5 cigarettes or an average daily alcohol intake of 15 g (15 g alcohol is equivalent to 450 ml beer or 150 ml wine or 50 ml low-alcohol liquor) within 3 months before screening; 13. subjects who cannot refrain from smoking and alcohol intake from 2 days before the start of study treatment until the last follow-up; 14. subjects who consume alcoholic beverages, seville oranges, grapefruit or juices, or products containing caffeine or xanthine (such as coffee, tea, cola drinks and chocolate) from 2 days before the start of study treatment, and those who have special dietary requirements and cannot comply with the unified diet; 15. subjects with a history of drug abuse, drug dependence, or a positive drugs of abuse test, or a positive alcohol breath test before study drug administration; 16. pregnant or lactating females; 17. other conditions judged by the investigator to be not suitable to participate in the trial;