Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis
Status:
Not yet recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
The proposed Phase 1b study design is a randomized, placebo-controlled, double-blind, study
to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.
The primary and secondary objectives of this study is to establish safety and
pharmacokinetics of orodispersible BT-11 in active eosinophilic esophagitis (EoE).
The exploratory objectives of this study will include effects on disease activity measured by
symptoms, endoscopy, histology and biomarkers, health-related quality of life,
pharmacokinetics, and safety.