Induced Pluripotent Stem Cell Derived Exosomes for the Treatment of Atopic Dermatitis

Inclusion Criteria:

• Age 18 to 70 years, body mass index (BMI) between 18 and 35 kg/m2 (including boundaryvalues);
• Overall good health except AD;
• Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajkacriteria;
• Investigator overall assessment (IGA) score of 2 to 3;
• Participants with a history of subacute or chronic AD symptoms for at least 6 months;
• Participants with body surface area (BSA) of AD involvement of ≤5% at screening andbaseline;
• Participants and their partners agreed to use effective contraception throughout thestudy period (from screening to 3 months after completion of treatment);
• Participants understood and voluntarily signed the informed consent form.

Exclusion Criteria:

• There are obvious active systemic or local infections, including but not limited tothe infection of AD secondary infection, local bacterial infection in target lesion,local viral infection in target lesion, and local fungal infection in target lesion.Note: After the infection resolves, the patients can be re-screened;
• Presence of any of the following conditions: HB surface antigen (HBsAg) positive and /or HB e antigen (HBeAg) positive, HB e antibody (HBeAb) and / or hepatitis B coreantibody (HBcAb) positive and hepatitis B virus deoxyribonucleic acid (HBV-DNA) copynumber> 2000 IU / mL; limited hepatitis C virus (HCV) antibody positive and peripheralblood hepatitis C virus (HCV) RNA positive; positive human immunodeficiency virus (HIV) antibody; positive for syphilis (TPA) test;
• Inoculate live or attenuated vaccine within 4 weeks before screening or during thestudy period;
• Received allergen specific immunotherapy within 6 months before screening;
• Use of topical drugs known or may affect AD within 2 weeks before screening (includingbut not limited to topical glucocorticoids; calcineurin inhibitors: such astacrolimus, pirolimus, etc.);
• Use of immunosuppressants and Janus kinase inhibitors within 4 weeks before screening;
• Use of any biological agent (such as IL-4 receptor inhibitors, IL-13 inhibitors) for 12 weeks before screening or 5 half-lives (whichever is longer);
• Received systemic or local Chinese medicine treatment (including Chinese medicineimmersion treatment) within 2 weeks before screening;
• Treated with UV and photochemistry within 4 weeks prior to screening;
• Required systemic treatment of antiviral, antiparasitic, antigenic, or antifungalswithin 4 weeks prior to screening;
• With significant abnormal findings or laboratory values and clinical significance,such as white blood cell count <3.0e9 / L; neutrophils <1 LLN; hemoglobin <90g / L;platelet <100e9 / L; serum creatinine> 1.5 ULN, ALT or AST 2 ULN; QTcF> 450 msec (male) or QTcF> 470 msec (female);
• Other combined (or co-occurrence) skin diseases that may affect the study evaluation,such as acne, psoriasis, lupus erythematosus, etc.; or large tattoos, birthmarks, skinscars, skin ulcers and other conditions that may affect the judgment of theinvestigator;
• Except for AD, any history of clinical major disease or clinically significantcirculatory system abnormality, endocrine system abnormality, neurological orhematological disorders, immune system disease, psychiatric illness and metabolicinstability; clinical significance is defined as the risk of the safety of the subjector aggravating the disease / disease during the study;
• Patients with a history of severe skin allergy and / or allergy to any ingredients ofthe product;
• History of cancer in the past 5 years (except for surgically removed squamous cellcarcinoma, basal cell carcinoma, or skin carcinoma in situ);
• Any major surgery within 8 weeks before screening; or subjects expected to undergosurgery during the trial or within 4 weeks after the end of the trial; or 400 mLnonphysiological blood loss (including trauma, blood collection, blood donation within 12 weeks before screening);
• Pregnant women, lactating women, or women who plan to become pregnant during the study (fertile women must have a urine pregnancy test with negative results);
• Subjects who are currently participating in other clinical trials or who haveparticipated in other clinical trials within 90 days;
• The investigator judged any other condition not suitable to participate in this study.