A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
Qpharm Pty Ltd
Herston, Queensland, Australia
University of the Sunshine Coast
Sippy Downs, Queensland, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Safety of Nexvax 2 administered subcutaneously (SQ)
Treatment emergent adverse events (TEAEs) will be summarized by treatment group and treatment arm, severity (grades as defined in CTCAE, Version 4.03), relationship to IP, and phase of treatment and presented as the number and percentage of patients reporting an event(s) as well as the number of events reported.
Time frame: Treatment Period: 7 weeks
Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration
Blood draws for plasma concentration
Time frame: Treatment Period: 7 weeks
Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID
Blood draw collected for cytokines
Time frame: Treatment Period: 7 weeks
Evaluate area under the plasma concentration-time curve for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Blood draw collected for Pharmacokinetic (PK) sample
Time frame: Treatment Period: 7 weeks
Compare elimination half life properties for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Blood draw collected for PK
Time frame: Treatment Period: 7 weeks
Compare time to maximal plasma concentration for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Blood draw collected for PK
Time frame: Treatment Period: 7 weeks
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