Covid-19 infection
Conditions
Interventions
Part A: Single 50 mg test drug group:Take the medicine once in total, the dose is 50 mg
Part A: Single 150 mg test drug group:Take the medicine once in total, the dose is 150 mg
Part A: Single 300 mg test drug group:Take the medicine once in total, the dose is 300 mg
Part A: Single 450 mg test drug group:Take the medicine once in total, the dose is 450 mg
Part A: Single 600 mg test drug group:Take the medicine once in total, the dose is 600 mg
Part A: single-dose control group:50mg single dose control group: 1 dose in total, placebo
150mg single dose control group: 1 dose in total, placebo
300mg single dose control group: 1 dose in total, placebo
450mg single dose control group: 1 dose in total, placebo
600mg single dose control group: 1 dose in total, placebo
Part B: Multiple 50 mg test drug group:Multiple doses: 50 mg twice a day for a total of 11 doses
Part B: Multiple 150 mg test drug group:Multiple doses: 150 mg twice a day for a total of 11 doses
Part B: Multiple 300 mg test drug group:Multiple doses: 300 mg twice a day for a total of 11 doses
Part B: Multiple-dose control group:Multiple-dose 50mg control group: 2 doses per day, placebo each time, for a total of 11 doses
Multiple-dose 150mg control group: 2 doses per day, placebo each time, for a total of 11 doses
Multiple-dose 300mg control group: 2 doses per day, placebo each time, for a total of 11 doses
Sequence A (Food influence Group):150 mg orally on an empty stomach, 5 days after washout, 150 mg orally after a high-fat meal
Sequence B (Food influence Group):150 mg orally after a high-fat meal, 5 days after washout, 150 mg orally on an empty stomach
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1). Volunteer to participate in this study and provide a signed and dated informed consent form; (2). Aged between 18 and 55 years old (including the critical value) at the screening visit, male or female; (3). Male subjects weigh no less than 50 kg and female subjects weigh no less than 45 kg. Body mass index is within the range of 19.0 ~ 26.0 kg/m2 (including the critical value); (4). The researcher judges that the subject is in good health and has no clinically significant abnormalities based on past medical history, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, etc.; (5). If the subject is a female: a. No reproductive potential, including surgically sterilized subjects (documented tubal ligation, hysterectomy or bilateral salpingectomy), and subjects who have been postmenopausal for more than 12 consecutive months of amenorrhea at the screening visit; b. If there is reproductive potential, must be non-pregnant, non-lactating, and must agree not to have children within 14 days before administration, during the study, and within 6 months after administration and take appropriate (non-drug) contraceptive measures; c. At the screening visit and D-1, the human chorionic gonadotropin (hCG) test result is negative; if the subject is a male subject and his female partner of reproductive potential must agree to take appropriate (non-drug) contraceptive measures within 14 days before administration, during the study, and within 6 months after administration; and male subjects must not donate sperm during this period; (6). Willing to comply with the visits, research treatments, laboratory tests and other research-related procedures and requirements specified in the study protocol.
Exclusion criteria
Exclusion criteria: (1). Allergic to the investigational drug or its excipients, or a history of severe allergies (including any food allergy or drug allergy); (2). Previous major central nervous system, respiratory system, cardiovascular system, digestive system, blood system, endocrine system, musculoskeletal disease, urinary system or tumor or any other disease or physical condition, or any current acute disease, or other disease or physical condition that the investigator determines may affect the study or pose an unacceptable risk to the subject; (3). Positive hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody (HCV-Ab), or positive human immunodeficiency virus antibody (HIV-Ab), or positive Treponema pallidum antibody (TP-Ab); (4). Resting systolic blood pressure (SBP) >140 or 90 or 100 or 450 ms for males, or > 470 ms for females; (7). Screening or baseline serum aspartate aminotransferase (ALT) or alanine aminotransferase (AST) or total bilirubin > upper limit of normal (ULN); (8). Glomerular filtration rate (GFR) calculated according to MDRD creatinine formula upper limit of normal (ULN); (9). History of drug abuse (such as morphine, methamphetamine, ketamine, MDMA, tetrahydrocannabinolic acid, cocaine, etc.), or positive baseline drug screening test; (10). Alcohol abuse within 1 year before screening (drinking more than 21 standard units per week, 1 standard unit contains 14 g of alcohol, such as 360 ml of 5% beer, 45 ml of 40% spirits, 120 ml of 12% wine ml), or a positive alcohol breath test at baseline; (11). Smoked more than 5 cigarettes a day within 3 months before screening, or failed to comply with the smoking ban during the study; (12). Used any drug that inhibits or induces liver drug metabolizing enzymes within 30 days before screening; consumed food or beverages that can induce or inhibit liver metabolizing enzymes (such as grapefruit, etc.) within 7 days before the start of the trial; disagreed or could not guarantee not to consume any food or beverages that contain or metabolize caffeine or xanthine (such as coffee, tea, chocolate) from 48 hours before the first dose of the trial to the completion of the last pharmacokinetic blood sample collection; (13). Received any vaccine within 30 days before screening, or planned to receive any vaccine during the study; (14). During the period from 14 days before administration (if the 5 half-lives of the drug used are longer than 14 days, the 5 half-lives shall prevail) to the last visit, it is not guaranteed that no drugs (except those allowed by the investigator) will be used, including prescription and over-the-counter drugs (excluding topical eye/nose drops and creams without systemic exposure risk), vitamins (excluding conventional vitamins), health products and Chinese herbal medicines; (15). Received any study drug treatment or participated in any drug/research device trial within 3 months before administration; (16). Underwent major surgery within 30 days before administration or planned to undergo major surgery during this study; (17). Currently pregnant or breastfeeding, or intending to become pregnant during the study; (18). Those who have donated blood or lost >= 400 ml of blood or received blood transfusion within 3 months b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;Physical examination;12-Lead Electrocardiogram;Routine blood test;Routine urine test;Blood biochemistry;Coagulation function;Five thyroid function tests;Serology;Pregnancy test (female subjects only);Ae; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;AUC;t1/2;CLz/F;Vz/F;MRT;Cmin,ss;Cmax,ss;Cav,ss;AUC0-t;Geometric mean ratio BA%; | — |
Countries
China
Contacts
Public ContactMeixian Wang
Beijing Jishuitan Hospital
Outcome results
None listed