NCT04835168
Withdrawn
Phase 1
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis
NImmune Biopharma0 sitesJanuary 30, 2022
ConditionsEosinophilic Esophagitis
Overview
- Phase
- Phase 1
- Intervention
- BT-11 low
- Conditions
- Eosinophilic Esophagitis
- Sponsor
- NImmune Biopharma
- Primary Endpoint
- Incidence and severity of AEs
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
The proposed Phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BT-11 low
Oral
Intervention: BT-11 low
BT-11 high
Oral
Intervention: BT-11 high
Placebo
Oral
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence and severity of AEs
Time Frame: 12 Weeks
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