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A Phase 1, First in Human, Randomized, Placebo-controlled Trial with a Controlled Gluten Challenge to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VTP-1000 in Adults with Celiac Disease

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Trial Profile

A Phase 1, First in Human, Randomized, Placebo-controlled Trial with a Controlled Gluten Challenge to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VTP-1000 in Adults with Celiac Disease

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 14 May 2025

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At a glance

  • Drugs VTP 1000 (Primary)
  • Indications Coeliac disease
  • Focus Adverse reactions; First in man
  • Acronyms AVALON
  • Sponsors Barinthus Biotherapeutics

Most Recent Events

  • 07 May 2025 According to a Barinthus Biotherapeutics media release, Phase 1 single ascending dose readout from AVALON expected in Q3 2025; multiple ascending dose expected to start in 2H 2025, incorporating a gluten challenge as part of initial clinical efficacy evaluation.
  • 20 Mar 2025 According to a Barinthus Biotherapeutics media release, Initiation of the multiple ascending dose portion of the Phase 1 AVALON clinical trial is expected in the second half of 2025.
  • 10 Jan 2025 According to a Barinthus Biotherapeutics media release, Phase 1 single ascending dose data expected in mid-2025. The multiple ascending dose portion of this study is expected to start in the third quarter of 2025.

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