Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

Status Completed

Clinical Trial Summary

A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).

Clinical Trial Description

A Phase 1, randomized,double-blind, placebo-controlled clinical study of Nexvax2, in adult subjects with confirmed CeD who, have been following a gluten free diet for at least 12 consecutive months prior to screening. The study will evaluate the safety and tolerability of Nexvax2 administered subcutaneously and will compare the bioavailability of subcutaneous versus intradermal administration. The study plan consists of 3 periods: a screening period of 3 to 5 weeks, a 46-day treatment period, and a 30-day post-treatment observational follow-up visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03543540
Study type	Interventional
Source	ImmusanT, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	May 1, 2018
Completion date	September 10, 2018

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