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
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of BxC-I17e Administered Subcutaneously in Patients With Moderate to Severe Atopic Dermatitis
Brexogen Inc.
45 participants
Apr 18, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- Patients (males or females) aged 18 years or older.
- Patients have documented history of moderate to severe AD, that has been present for at least 1 year
- History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD
- 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.
- Willingness and ability to comply with clinic visits and study-related procedures.
- Patients should be able to read, understand, and be willing to sign the ICF
Exclusion Criteria16
- 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
- Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
- Active dermatologic conditions that may confound the diagnosis of AD
- Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study
- Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the patient's participation in this study
- Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit.
- Known history of human immunodeficiency virus (HIV) infection
- Pregnant or breastfeeding women
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Interventions
Pharmaceutical form : solution for injection
Pharmaceutical form : solution for injection
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06055361