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

NImmune Biopharma

Status and phase: Withdrawn; Phase 1

Conditions: Eosinophilic Esophagitis

Treatments: Drug: BT-11 low; Drug: Placebo; Drug: BT-11 high

Study type: Interventional

Funder types: Industry

Identifiers

NCT04835168

BT-11-EoE

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

No patients enrolled

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups, including a placebo group

BT-11 low

Experimental group

Description:

Oral

Treatment:

Drug: BT-11 low

BT-11 high

Experimental group

Description:

Oral

Treatment:

Drug: BT-11 high

Placebo

Placebo Comparator group

Description:

Oral

Treatment:

Drug: Placebo