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

NImmune Biopharma

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Eosinophilic Esophagitis

Interventions

BT-11 lowDRUG

Oral

BT-11 highDRUG

Oral

PlaceboDRUG

Oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

No patients enrolled

Outcomes

Primary Outcomes

Incidence and severity of AEs

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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