Atopic Dermatitis
Conditions
Interventions
Experimental group:GR1802 injection
Control group:Placebo
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 70 years (including both ends) one year old; 2.Weight >= 40kg; 3.Subjects with atopic dermatitis (according to the American Academy of Dermatology consensus criteria, 2014) diagnosed at least 12 months before the screening visit; 4.Eczema Area and Severity Index (EASI) score >= 16 at screening visit and baseline visit; 5.Investigator's global assessment (IGA) score >= 3 at the screening visit and baseline visit; 6.Atopic dermatitis (AD) involving body surface area (BSA) >= 10% at screening visit and baseline visit; 7.Be able to understand and comply with the requirements of the clinical program, voluntarily participate in clinical trials, and the patients or their legal representatives sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1.History of lymphoproliferative disease upon inquiry; or currently suffering from malignant tumor or a history of malignant tumor (cutaneous squamous cell carcinoma in situ, except basal cell carcinoma and cervical carcinoma in situ, has achieved complete remission after radical treatment without any sign of recurrence for more than 5 years); 2.History of important organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation; 3.Have received live/attenuated vaccine within 8 weeks before screening or plan to receive live/attenuated vaccine during the trial; 4.Suspected or confirmed allergy to the investigational drug (including excipients and similar drugs), and other serious allergic diseases (except this disease) that may compromise the safety of the subjects as judged by the investigator; 5.Alcoholism (defined as: drinking more than 28 units of alcohol per week (1 unit = 285ml of beer or 25ml of spirits with an alcohol content of >=40% or 1 glass of wine) and/or drugs within 6 months prior to screening history of abuse; 6.Donated blood >= 300mL within 4 weeks before screening (except for female physiological blood loss), or planned to donate blood during the trial or within 4 weeks after the end of the trial (inquiry); 7.Females and/or males of childbearing potential and their partners refuse to sign the informed consent form to within 6 months of the last administration: those who take effective contraceptive measures, those who have children, egg donation programs (women) or sperm donation programs ( male); 8.Hypertension with poorly controlled blood pressure (systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg. Note: Determined by 2 consecutive elevated readings. If the initial blood pressure reading exceeds this limit, the subject can rest >= Re-measure blood pressure after 10 minutes. If the repeat measurement is below the limit, a second value can be accepted); 9.The following laboratory abnormalities at screening: Hemoglobin (male) 1.5 times the upper limit of normal (ULN) Serum creatinine > ULN Total bilirubin > 1.5 times ULN Alkaline phosphatase > 1.5 times ULN; 10.Hepatitis B surface antigen positive at screening (except HBV DNA test less than 500IU/ml), hepatitis B core antibody positive (HBV DNA test less than 500IU/ml); hepatitis C virus antibody positive, human immunodeficiency virus (HIV) antibody positive, anti-syphilitic spiral antibody (TP-Ab) positive (except RPR or TRUST negative); 11.There is a 12-lead ECG abnormality that the investigator considers to be clinically significant at the time of screening and may increase the risk of the subject; 12.Lactating women who are pregnant or need to breastfeed; 13.Receiving biologics treatment: within 5 half-lives (if the half-life is known) or 16 weeks (whichever is longer) before the baseline visit; 14.Participated in other clinical trials and enrolled for treatment within 4 weeks before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;Immunogenicity index;Eczema area and severity index;Daily peak visual simulation score; | — |
Countries
China
Contacts
Public ContactXu Jinhua
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed