A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single and Multiple Dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
Trial Parameters
Brief Summary
The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of a single and multiple SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)
Eligibility Criteria
Inclusion Criteria: 1. Patients (males or females) aged 18 years or older. 2. Patients have documented history of moderate to severe AD, that has been present for at least 1 year 3. History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD 4. Patients must agree to apply stable doses of additive-free, basic bland emollient lotions twice daily for at least 7 days before the Baseline Visit. 5. Willingness and ability to comply with clinic visits and study-related procedures. 6. Patients should be able to read, understand, and be willing to sign the ICF Exclusion Criteria: 1. Presence of any of the following laboratory abnormalities * Hemoglobin \< 11 g/dL * WBC \< 3.5 × 103/μL * Platelet count \< 125 × 103/μL * Neutrophils \< 1.75 × 103/μL * AST/ALT \> 1.5 × ULN * Total bilirubin \> ULN * Creatinine \> ULN * Creatine phosphokinase \> ULN 2. Positive test for hepatitis B surface antigen, and/or hepatitis C antibody 3. Active dermatologic conditions that may co