moderate-to-severe atopic dermatitis
Conditions
Interventions
Group 1 (Part A):A single subcutaneous injection of 150 mg of QX027N or placebo
Group 2 (Part A):A single subcutaneous injection of 450 mg of QX027N or placebo
Group 3 (Part A):A single subcutaneous injection of 900 mg of QX027N or placebo
Group 4 (Part A):A single subcutaneous injection of 1200 mg of QX027N or placebo
Group 5 (Part A):A single intravenous injection of 450 mg of QX027N or placebo
Group 1 (Part B):Multiple subcutaneous injections of 300 mg QX027N or placebo
Group 2 (Part B):Multiple subcutaneous injections of 600 mg QX027N or placebo
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part A Healthy subjects for Part A must meet all the following inclusion criteria: 1.Healthy adults who are aged 18 to 50 (inclusive) years at the time of signing the informed consent form; 2.Male subjects weighing >= 50 kg, female subjects weighing >= 45 kg, and both =1 year prior to screening (date of first symptom onset being the earliest occurrence), whilst all of the following conditions are satisfied: (1) EASI score>=16 at both screening and randomisation; (2) IGA score>=3 at both screening and randomisation (0—4-point IGA scale, where 3 for moderate and 4 for severe); (3) BSA>=10% at both screening and randomisation; (4) Weekly mean PP-NRS score>=4 at randomisation; Note: The baseline PP-NRS will be determined by the mean of daily NRS scores for the maximum itch intensity (daily scoring range from 0 to 10) within the 7 days prior to randomisation. A minimum of 4 out of 7 days' scores shall be required to calculate the baseline mean score. If a subject reports less than 4 days within the 7 days preceding the originally scheduled randomisation date, randomisation will be delayed until the requirement is met, but should not exceed the maximum screening period of 28 days. 4. As determined by the investigator: the subject exhibits inadequate response to or is unsuitable for medium-to-higher potent TCS or other topical medications. (This includes significant adverse effects or safety risks, such as severe local infection, skin atrophy, telangiectasia, etc.); Note: Inadequate response is defined as: (1) Continuous use of medium-to-higher potent TCS for >=28 days or reaching the maximum course recommended in the product information (e.g., >=14 days for ultra-potent TCS) within the year preceding baseline, yet failure to achieve and maintain remission or low disease activity (equivalent to IGA 0-2); or (2) Receipt of standardised systemic treatment for AD within the year preceding baseline. 5. Apply a stable dose of emollient to the affected AD lesion areas twice daily for consecutive 7 days before randomization. If the above requirement is not met within the 7 days preceding the originally scheduled randomisation date, randomisation shall be deferred until compliance is achieved, but must not excee
Exclusion criteria
Exclusion criteria: Part A Participants will be unable to participate in the study if any of the following exclusion criteria are met: 1. Pregnant or lactating females, or subjects planning pregnancy or lactation during the study period; 2. Subjects with prior exposure to drugs targeting TSLP or IL-13; 3. Subjects with a known history of drug or other allergies deemed by the investigator to pose a high risk for participation, or those judged by the investigator to be potentially allergic to the study drug or any of its components; 4. Subjects with positive HBsAg or anti-HBc at screening; or subjects with positive for hepatitis C antibody, treponema pallidum antibody, or non-negative HIV antibody; 5. Chronic active or acute infections requiring treatment with systemic antibiotics, antivirals, antiparasitics, anti-protozoals, or antifungals within 2 weeks prior to baseline visit; or superficial skin infections occurring within 1 week prior to baseline visit; 6. Diagnosis of active parasitic infection; suspected or high-risk endoparasitic infection, unless active infection has been excluded by clinical and (where necessary) laboratory assessment prior to randomisation. 7. Possible active tuberculosis infection at screening, or history of active tuberculosis; 8. Presence of any disease considered clinically significant and affecting the study by the investigator prior to randomisation, including but not limited to disorders of the nervous, cardiovascular, respiratory, haematological, endocrine, urinary, digestive, skeletal, metabolic, psychiatric, infectious, ophthalmic, or gynaecological (female subjects) systems; 9. Laboratory test results meeting any of the following criteria at screening or baseline examination: (1) AST/ALT> 1.2 times the upper limit of normal (ULN), or TBIL > 1.5 times ULN; (2) SCr > ULN; (3) Other abnormal laboratory findings deemed by the investigator to potentially affect subject completion of the trial or interfere with trial results; Note: If the subject has abnormal laboratory findings at screening, the investigator may, if deemed necessary, permit a scheduled retest on a different day within 28 days of screening. If the retest results are acceptable, the subject may be enrolled (no drug intervention for the abnormal laboratory findings is permitted prior to retesting). 10. Those with known or suspected history of immunosuppression, history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumonocystosis, aspergillosis) should be excluded even if the infection has resolved, or those with unusual frequent, recurrent, or prolonged infections; 11. Major surgery or procedures potentially affecting outcome assessment undergone within 3 months prior to screening or planned during the study period; 12. Malignant neoplasms or history of malignancy; 13. History of blood transfusion; or blood donation or blood loss (other than from donation) =200mL within 8 weeks prior to screening; 14. Individuals who have received live (attenuated) vaccines within 4 weeks prior to screening or who plan to receive live (attenuated) vaccines during the trial period; 15. Use of any prescription medication or traditional Chinese herbal medicine within 4 weeks prior to screening or 5 half-lives (whichever is longer), or during the screening period; 16.Those who have a weekly alcohol consumption of more than 14 units of alcohol (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with alcohol content of 40% or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Safety ;Part B: Safety ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Pharmacokinetics and Immunogenicity;Part B: Pharmacokinetics and Immunogenicity; | — |
Countries
China
Contacts
Public ContactYing Wang; Liming Wu
Hangzhou First People's Hospital
Outcome results
None listed