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

Phase 1

Withdrawn

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: BT-11 high; Drug: Placebo; Drug: BT-11 low

• Registration Number: NCT04835168
• Lead Sponsor: NImmune Biopharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Study Start: 2022-01-30
• Primary Completion: 2022-04-30
• Study Completion: 2022-06-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BT-11 high	BT-11 high	Oral
Placebo	Placebo	Oral
BT-11 low	BT-11 low	Oral

Primary Outcome Measures

Name	Time	Method
Incidence and severity of AEs	12 Weeks