Atopic dermatitis
Conditions
Interventions
Group 1:single dose escalation
Group 2:multiple dose escalation
Group 3:take QY201 tablets orally on an empty stomach or after eating a high-fat and high-calorie standard meal in the morning of Day 1 and Day 6
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily serve as subjects, and sign an informed consent form before any research procedure begins; 2. Subjects aged 18 to 45 years(including 18 and 45), no gender limit; 3. Male weight >= 50.0 kg, female weight >= 45.0 kg; body mass index (BMI) within the range of 19.0 - 26.0 kg/m^2 (including the critical value); 4. The subjects have no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, respiratory, blood and lymph, endocrine, immune, mental, neurological, gastrointestinal system, etc., and have good general health; 5. Physical examination, vital signs, clinical laboratory test values (blood routine, urine routine, blood biochemistry, coagulation function, stool routine + occult blood, pregnancy test (female), hepatitis, HIV, syphilis), 12-lead electrocardiogram, chest X-ray, abdominal ultrasound, drug abuse testing, nicotine testing, and alcohol testing results are within the normal range or have no clinical significance; 6. Subjects (including male subjects) have no plans to become pregnant during the screening period until 6 months after the end of the last dose, voluntarily take effective contraceptive measures, and have no plans to donate sperm or eggs; 7. The subjects can communicate well with the researchers, and understand and comply with the requirements of this research.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution, such as those with a history of allergies to two or more drugs and food, or those who are known to be allergic to the components of this drug (Lactose Monohydrate Microcrystalline Cellulose Colloidal Silica Croscarmellose Sodium and Magnesium Stearate); 2. A history of dysphagia or any gastrointestinal disease that affects drug absorption; 3. Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, or who have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion; 4.Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bone and other systems; 5.Those who cannot tolerate venipuncture, those who have a history of needle fainting or haemorrhage; 6. Lactose intolerance (those who have had diarrhea due to drinking milk)[only for the study of the effect of food on pharmacokinetics] and or those who have special requirements for diet and cannot comply with a unified diet ; 7. Smoking or drinking within 3 months before screening (smoking: >10 cigarettes/day; drinking: >15 g pure alcohol/day, equivalent to 450 mL of beer, 150 mL of wine or 50 mL of low-alcohol liquor),or positive for nicotine, alcohol, substance abuse (morphine/methamphetamine/ketamine/dimethylene dioxyamphetamine/THC); 8. Those who have participated in other drug clinical trials within 3 months before screening or who did not participate in clinical trials by themselves; 9. Those who donated blood, including blood components or blood loss (>=200 mL), received blood transfusion or used blood products within 3 months before screening; 10. The subject (female) is breastfeeding; 11. Have used strong inhibitors or strong inducers of CYP3A liver metabolic enzymes, sensitive substrates of CYP1A2, CPY2B6 and CYP3A liver metabolic enzymes, inhibitors of P-gp and BCRP efflux transportersor taken any drugs, including prescription drugs, Over-the-counter medicines and herbal remedies, except vitamins and/or paracetamol (Paracetamol); 12. Those who drink excessive tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months before screening; 13. For patients with clinically significant abnormalities in vital signs examination, the reference range of the standard of entry and exit (including the critical value): systolic blood pressure 90-139 mmHg in sitting position, diastolic blood pressure 55-89 mmHg, pulse 55-100 beats/min, body temperature 36.0-37.4°C, respiration 16-22 times/min; if the first test result of the subject is abnormal, a retest can be performed after resting; 14. Subjects judged by other researchers to be inappropriate to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event;pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactRuan Zourong
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed