رادار التجارب السريرية

Participants who meet any of the following criteria will not be enrolled in the study:

1. Those with general conditions:

   1. Female participants who are pregnant (pregnancy is defined as the state from conception until the termination of pregnancy), lactating, or have a positive serum human chorionic gonadotropin test result;
   2. Alcohol abuse (ie, an average weekly consumption of >14 units of alcohol \[1 unit ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine\]) and/or drug abuse within half a year before screening;

2. Those who experience any of the following in laboratory tests and/or electrocardiogram (ECG) at screening or baseline (if necessary, a repeated test can be conducted for confirmation):

   1. Hemoglobin <100.0 g/L (males), or <90.0 g/L (females);
   2. White blood cell count <3.0 × 109/L;
   3. Neutrophil count <1.5 × 109/L;
   4. Platelet count <100 × 109/L;
   5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × ULN;
   6. Bilirubin total (T-BIL) >1.5 × ULN;
   7. Serum creatinine >1.5 × ULN;
   8. A positive hepatitis B surface antigen (HBsAg) test result, a positive hepatitis B core antibody (HbcAb) test result with HBV DNA level above the upper limit of the normal range, or the HIV and anti-hepatitis C virus (HCV) antibody test results are positive with positive HCV RNA, or syphilis infection is present (when the syphilis specific antibody test result is positive, the non-specific antibody test for syphilis shall be added for validation).
   9. ECG at screening indicates clinically significant abnormalities that may affect the safety of participants, including but not limited to acute myocardial ischemia, myocardial infarction, serious arrhythmia or significant QTcF prolongation (QT interval corrected by Fridericia's formula, QTcF ≥450 ms for males and ≥470 ms for females);

3. Those with any of the following medical history or comorbidities:

   1. History of vernal keratoconjunctivitis (VKC) and/or atopic keratoconjunctivitis (AKC); or active dermatosis that may confound the diagnosis of AD or interfere with the evaluation of treatment (eg, psoriasis, body tinea, cutaneous lupus erythematosus), generalized pigmentation or extensive scarring, or other types of eczema (allergic contact dermatitis);
   2. Known or suspected history of immunosuppressive diseases, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, or aspergillosis), although having been relieved; or abnormally frequent, recurrent or long-term infections as judged by the investigator;
   3. Participants with chronic active or acute infections requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before screening or from screening to baseline;
   4. Those with current evidence of active tuberculosis (TB) or occult TB infections (abnormal chest CT results determined by research show the presence of active TB, and suspected latent or old TB lesions can be confirmed by QuantiFERON Gold test at the discretion of the investigator);
   5. Those definitively diagnosed with lymphoma, leukemia, or any malignant tumor within 5 years before screening (except squamous cell carcinoma of skin, basal cell carcinoma, or carcinoma cervix in situ that is completely resected without evidence of recurrence);
   6. Previous or current significant medical diseases that will interfere with the study process and/or evaluation, as considered by the investigator, including but not limited to cardio-cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, nervous system and psychiatric diseases, as well as other conditions that are inappropriate for participation in the study, as judged by the investigator;
   7. The participant has a history of allergy to SM17 or its components, or a history of immediate allergy to other drugs (as defined by Sampson criteria), a history of allergy to monoclonal antibodies and their components, clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity (including but not limited to severe erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome, and dermatitis exfoliative); Notes: Sampson criteria: 1.) Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of respiratory compromises, reduced blood pressure (BP) or associated symptoms of end-organ dysfunction; 2.) Any 2 or more of the above symptoms that occur rapidly after exposure to a likely allergen for that patient; 3.) Reduced BP after exposure to known allergen for that participant.

4. Those who use any of the following medications/treatments and are not expected to withdraw/discontinue such treatment(s) throughout the study:

   1. Systemic application of corticosteroids, immunosuppressants, Janus kinase inhibitors for AD within 4 weeks before baseline;
   2. Antihistamines or inhaled corticosteroids within 1 week before baseline (those who have been treated with antihistamines or inhaled corticosteroids at a stable dose for at least 7 days before baseline and are scheduled to continue to use them during the study may be enrolled);
   3. Systemic herbal therapy for AD within 4 weeks before baseline;
   4. Ultraviolet therapies for AD (including but not limited to narrow-band ultraviolet B \[NB-UVB\] or medium-to high-dose UVA1) or regular use of artificial sunbathing for AD within 4 weeks before baseline;
   5. ≥2 bleach baths within 2 weeks before baseline;
   6. The following topical medications for the treatment of AD within 1 week before baseline: a) Topical corticosteroids or topical calcineurin inhibitors; b) Other alternative therapy including topical traditional Chinese medicines; c) Other topical medications (including but not limited to topical phosphodiesterase-4 \[PDE-4\] inhibitors);
   7. Those who have received biologics for AD before baseline: a) Any cell scavenger and/or cell depleting agent, including but not limited to rituximab; b) Other biologics: within 5 half-lives (if known) or 16 weeks before baseline, whichever is longer;
   8. Those who have received allergen-specific immunotherapies within 6 months before baseline;

5. Those who have used prescription emollients or emollients containing active ingredients (eg, ceramides, hyaluronic acid, urea, or filaggrin degradation products) within 1 week before baseline;

6. Those who have undergone major surgery within 3 months before baseline or who have not yet recovered after the surgery, or who plan to undergo major surgery during the study;

7. Those who have a history of blood donation or severe blood loss (total blood volume ≥500 mL) within 1 month before screening, or have received transfusion within 2 months before screening; or who have donated bone marrow stem cells within 3 months before screening;

8. Those who have received an attenuate live vaccine within 3 months before baseline, or plan to receive an attenuated live vaccine during the study;

9. Those who have participated in other interventional clinical studies (have signed an ICF and received active drug/device treatment) within 6 months before baseline;

10. Those who have participated in an anti-IL-25 antibody, or anti-IL-17RB antibody (including SM17) clinical study; Those who have had other conditions within 12 months before screening that, in the opinion of the investigator, may pose a risk to the participants' participation in this study or may interfere with study procedures