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.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 Cr…
Interventions
- DrugBxC-I17e (primed iMSC derived Extracellular vesicles(EV))
Pharmaceutical form : solution for injection
- DrugPlacebo
Pharmaceutical form : solution for injection
Locations (3)
- Arkansas Research TrialsNorth Little Rock, Arkansas
- DermDox Centers for DermatologyCamp Hill, Pennsylvania
- University of PennsylvaniaPhiladelphia, Pennsylvania