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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
RecruitingPhase 1
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
Who can join
Ages 18 and older · All sexes
Full 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 confound the diagnosis of AD 4. Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study 5. 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 6. Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit. 7. Known history of human immunodeficiency virus (HIV) infection 8. Pregnant or breastfeeding women
About the study
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)
What is being tested
- BxC-I17e (primed iMSC derived Extracellular vesicles(EV)) (drug)
- Placebo (drug)
Sponsor: Brexogen Inc. · Participants: 45 · Started: Apr 18, 2023
Contact the study team
- Hugh Lee · Phone: 1-301-540-2600
Official record on ClinicalTrials.gov — NCT06055361
Locations in the U.S.
| Arkansas | Arkansas Research Trials, North Little Rock |
| Pennsylvania | DermDox Centers for Dermatology, Camp Hill University of Pennsylvania, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.