Atopic Dermatitis
Conditions
Interventions
experimental group:PG-011Gel, external applying, once daily
control group:placebo, external applying, once daily
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adolescents 12 years old= age<18, male or female. 2. Weight = 40 kg. 3. Vital signs, physical examination, abdominal color ultrasound, chest X-ray examination and laboratory examination were normal or abnormal which has no clinical significant judged by investigator. 4. Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol. 5. Willingness to sign the Informed Consent Form and comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Participant has mental illness or hereditary diseases history, or past medical history of serious cardiovascular, respiratory, liver, kidney, digestive, nervous, endocrine, urinary and other diseases. 2. Participant has oncology diseases history. 3. Participant has tuberculosis history and has herpes zoster within 1 year before screening. 4. Participant has positive test result: Hepatitis B surface antigen, hepatitis C virus antibody, hepatitis C virus core antigen, human immunodeficiency virus [HIV] antigen antibody combined detection, treponema pallidum specific antibody . 5. Abnormal ECG examination has clinical significance, such as: QTc > 450 ms (male) or QTc > 470 ms (female). 6. Participant has undergone major surgery within 3 months prior to screening or plan to undergo surgery during the trial period. 7.Participants are allergic to the investigational drug and any of its components or related preparations (for example, people who are allergic to two or more drugs or foods), or who are considered by the investigator to be at risk of allergy or intolerance to the test drug; 8. Participants who have used any drugs (including topical drugs) or health care products within 2 weeks before starting using the test drugs. 9. Participants who have taken drugs within 3 months before screening or have a history of drug abuse within 12 months, or those who are positive for urine drug abuse screening. 10. Smokers who smoked > 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the test. 11. Average alcohol intake more than 2 units per day in the 3 months before screening (1 unit =285 mL beer, or 25 mL spirits, or 100 mL wine) or alcohol screening results positive. Or can not guarantee to stop drinking alcohol and alcohol products during the period from signing the informed consent to the end of the study; Or excessive daily consumption of tea (> 15g tea/day), coffee or caffeinated beverages (> 500mg/ day) (1 cup of coffee contains about 85mg of caffeine). 12. Participants who donate blood or lose a lot of blood (>= 400mL, excluding blood loss during normal menstrual period in women), receive blood transfusion or use blood products within 3 months before administration. 13. Participants who are breastfeeding or pregnant. 14. Participants who received the vaccine within 4 weeks before starting using the test drugs. 15. The skin in the application area has broken, damaged, sunburn, redness, rash, abnormal fever, large tattoo, birthmark, skin scar, skin perforation, skin thinning, etc., and does not agree to shave the skin hair in the area. 16. Participants who cannot tolerate venipunction and have a history of fainting needles and fainting blood. 17. Participants who have participated in any other clinical trial within 3 months before screening. 18. Other conditions that the investigator deemed inappropriate for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event, AE;12-lead electrocardiogram;Clinical laboratory examination;Physical examination;Vital sign;Evaluation of local skin tolerance;Cmax;Tmax;AUC0-t;Serious adverse events, SAE ;AUC0-inf;t1/2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Apparent clearance, CL/F;Apparent volume of distribution, V/F; | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan (Hangzhou) Hospital
Outcome results
None listed