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

NCT04835168 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-06-07

No results posted yet for this study

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

DRUG

BT-11 low

Oral

DRUG

BT-11 high

Oral

DRUG

Placebo

Oral

Sponsors & Collaborators

  • NImmune Biopharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-30
Primary Completion
2022-04-30
Completion
2022-06-30
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04835168 on ClinicalTrials.gov