NCT04835168

Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NImmune Biopharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	BT-11 low	Oral
DRUG	BT-11 high	Oral
DRUG	Placebo	Oral

Timeline

• Start date: 2022-01-30
• Primary completion: 2022-04-30
• Completion: 2022-06-30
• First posted: 2021-04-08
• Last updated: 2023-06-07

Regulatory

• FDA-regulated drug study