hand-foot-and-mouth disease
Conditions
Interventions
Single dose escalation test - Group 1 (Dose escalation experiment):Oral fasting, 10mg, single dose
Single dose escalation test - Group 2 (Dose escalation experiment):Oral fasting, 30mg, single dose
Single dose escalation test - Group 3 (Dose escalation experiment):Oral fasting, 100mg, single dose
Single dose escalation test - Group4 (Dose escalation experiment):Oral fasting, 200mg, single dose
Single dose escalation test - Group5 (Dose escalation experiment):Oral fasting, 300mg, single dose
Single dose escalation test - Group6 (Dose escalation experiment):Oral fasting, 400mg, single dose
Single dose escalation test - Group8 (Dose escalation experiment):Oral fasting, 600mg, single dose
Single dose escalation Test - Group 7- Group A (Food influence Test):On the first day, KY0467 or placebo was taken orally on an empty stomach, tentatively 500mg/ time
On day 5, after eating high-fat and high-calorie food, KY0467 or placebo was taken orally, tentatively 500mg/ time.
Single dose escalation Test - Group 7- Group B (Food influence Test):On day 1, after eating high-fat and high-calorie food, take KY0467 or placebo orally, tentatively 500mg/ time
On day 5, KY0467 or placebo was taken orally on an empty stomach, tentatively 500mg/ dose.
Multiple dose escalation test - Group 9:50mg/ dose orally KY0467 or placebo (on an empty stomach or after eating as determined by the results of the food impact trial study), twice daily from day 1 to
Multiple dose escalation test - Group 10:100mg/ dose orally KY0467 or placebo (on an empty stomach or after eating as determined by the results of the food impact trial study), twice daily from day 1
Multiple dose escalation test - Group 11:200mg/ dose orally KY046
Sponsors
Beijing Hospital Clinical Trial Research Center
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) At the time of screening, the healthy subjects were aged 18-45 years old (including the boundary value of both ends), and the gender was not limited; (2) Body mass index (BMI) of 19.0-26.0 kg/m2 (including the boundary values at both ends); (3) According to the results of medical history, physical examination, electrocardiogram, laboratory examination (blood routine, blood biochemistry, coagulation function, urine routine), chest radiograph, etc., he/she was in good health, and no abnormalities of clinical significance were found. (4) Have fully understood this study, voluntarily participated in it, and have signed the informed consent. (5) The subject warrants and agrees that non-drug methods of contraception (such as condoms or intrauterine devices) must be used with a sexual partner of childbearing age for 30 days from the signing of the informed consent to the last dose.
Exclusion criteria
Exclusion criteria: (1) Pregnant (or positive blood pregnancy test), breastfeeding women; (2) Clinically significant cardiovascular, respiratory, digestive, endocrine, metabolic, neurological, skin, ophthalmic, infectious and psychiatric diseases or abnormalities; (3) have taken any medication, including over-the-counter and herbal medicines (other than vitamins), in the 4 weeks prior to taking the trial drug; (4) prior surgery that may affect the results of the clinical trial (including but not limited to any eye surgery, cholecystectomy, subtotal gastrectomy, etc., except minor surgery such as the removal of body surface lipoma); (5) Blood loss or blood donation exceeding 400 mL within 2 months before participating in the screening test; (6) Have any clear history of allergy; (7) Drinking history. Drinking more than 14 standard alcohol units per week in the past 1 year (1 standard alcohol unit is equivalent to about 250ml of 5% alcohol beer; Or 12.5% alcohol wine 100ml; Or spirits with an alcohol content of 42% (30ml); (8) Have a history of smoking (average daily smoking =5 cigarettes within 1 month before participating in the screening) or do not agree to prohibit smoking during the test; (9) Have a history of drug abuse or positive urine screening results; (10) Have participated in other clinical trials within 3 months before participating in the screening of this trial; (11) During screening, alcohol breath test results were > 0.0mg /100mL; (12) Hepatitis B virus surface antigen, syphilis specific antibodies, hepatitis C antibodies, AIDS antibodies any of the positive subjects; (13) Systolic blood pressure < 90mmHg or =140 mmHg and diastolic blood pressure < 60mmHg or =90mmHg during screening; (14) At the time of screening, ophthalmic examination (cornea, lens, fundus) found clinically significant abnormalities. (15) Any situation that the investigator believes will pose a safety risk to the subject during the study or may interfere with the conduct of the study, or the investigator believes that the subject may not be able to complete the study or comply with the requirements of the study (for administrative reasons or otherwise).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Vital signs (blood pressure, body temperature (ear temperature), pulse rate);Physical examination (including skin, ears, nose, throat, neck, chest, abdomen, spine/limbs, nervous system, superficial lymph nodes);12-lead electrocardiogram;Eye examination: Examination of cornea, lens and fundus;Time to peak;Peak concentration;Area under the plasma-drug concentration-time curve ;Apparent volume of distribution;Plasma clearance;Plasma elimination half-value period;Mean residence time;Urine concentration of KY0467;The rate at which drugs are excreted through the kidney;The total amount of drug excreted by the kidney;Steady-state peak time;Steady-state peak concentration;Steady state trough concentration ;Mean steady plasma-drug concentration;Area under the steady plasma-drug concentration-time curve ;Coefficient of fluctuation between peak concentrations;Ratio of accumulation;Index of accumulation;Medicine valley;Laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine); | — |
Countries
China
Contacts
Public ContactShi Aixin
Beijing Hospital Clinical Trial Research Center
Outcome results
None listed