A Study of Hemay005 in Adult With Atopic Dermatitis
Hemay005, Atopic Dermatitis
About this trial
This is an interventional treatment trial for Hemay005, Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria: Understand and voluntarily sign the informed consent form for this study; 18-75 years old (including boundary value) , gender is not limited; Ability to adhere to follow-up schedules and other program requirements; According to Hanifin & Rajka diagnostic criteria of atopic dermatitis (AD) , the patients with AD history ≥6 months; At baseline, the severity of AD was moderate to severe: IGA score was 3 or more, and the area of involved skin lesion was 10% BSA or more; Participants were required to use contraception during the study period. Exclusion Criteria: A medical history unsuitable for participation in a clinical study; Pregnant or lactating women; Allergic to the drug or its preparation; Patients who had undergone major surgery within 6 months before screening or who were scheduled for major surgery during the trial period; Participants who had participated in any drug or device clinical trial within the previous 3 months were screened; Vaccination with live or attenuated vaccines is planned for the duration of the trial; Any drugs is taking that may affect the effectiveness evaluation; Any clinically significant abnormality in 12-lead ECG at screening that was judged by the investigator as unsuitable for inclusion; When investgater believe that any condition could lead to unnecessary risks for patients participating in the study.
Sites / Locations
- First Hospital of Hebei Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
placebo
Hemay005 60mg
Hemay006 75mg
Atopic dermatitis patients treated with placebo for 12 week.
Atopic dermatitis patients treated with Hemay005 60mg BID for 12 week.
Atopic dermatitis patients treated with Hemay005 75mg BID for 12 week.