Atopic dermatitis (AD)
Conditions
Interventions
Group 1 (body weight >=60kg):NA
Group 2 (30kg< = body weight < = 60kg):SHR-1819 injection was administered
Group 3 (15kg<=body weight <=30kg):SHR-1819 injection was administered
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Subjects and their parents or legal guardians voluntarily sign the informed consent form before the start of any procedures related to the study, be able to communicate smoothly with the investigator, understand and be willing to strictly comply with the requirements of this clinical study protocol to complete the study; 2. At the time of signing the informed consent, the subjects are >=6 years old and =16; b) IGA score >=3; c) BSA>=10 %; 5. Daily Peak Pruritus Numeric Evaluation Scale (PP NRS) score within 7 days prior to the first dose with a mean value of >=4 points (at least 5 of which need to be collected for 5 of these days); 6. At least 1 of the following, as judged by the investigator, within 6 months prior to screening: a) Subjects who are treated with intermediate-potency or above topical glucocorticoids (TCS) but have a poor response; b) If the subject has used systemic therapy (including systemic glucocorticoids, or immunosuppressants or JAK inhibitors, etc.), it is considered to have a poor response to topical drugs; c) Subjects who are not suitable for topical drug treatment (e.g., intolerance or contraindications, etc.); 7. A stable dose of topical emollients (moisturizers) should be applied twice daily for at least 7 consecutive days before the first dose and continued for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. General situation: (1) Subject weight =400 mL or Subjects under 12 years of age who have donated or lost blood within 8 weeks prior to baseline >=200 mL and/or have a planned blood donation during the study; (5) History of alcohol abuse (i.e., drinking more than 14 units of alcohol per week [1 unit = 360 mL of beer or 45 mL of spirits or 150 mL of wine]) or illicit drug abuse within 6 months prior to screening; 2. Within 4 weeks prior to the first dose, the following conditions have occurred in laboratory tests and/or 12-lead ECG: (1) Hemoglobin (male) 3 times the upper limit of normal ULN; (6) Total bilirubin (T-BIL)) > 1.5 times ULN; (7) The estimated glomerular filtration rate (eGFR) estimated by Schwartz's equation =2 times), disseminated herpes zoster or disseminated herpes simplex within one year prior to screening; (7) Suspected or confirmed active tuberculosis (TB) (one of the following conditions is met a) Presence of active TB or clini
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic index;Immunogenicity index;Investigator overall assessment (IGA), eczema area and severity Index EASI, and idiosynthy Sexual dermatitis involved body surface area (BSA) and peak itch digital assessment scale PP-NRS Children's;Pharmacodynamic index; | — |
Countries
China
Contacts
Public ContactXinghua Gao
The First Hospital of China Medical University
Outcome results
None listed