NCT05682222

Evaluation of the Immunopharmacology of EDP1815 and EDP2939

A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Dose Platform Study Investigating the Immunopharmacology of EDP1815 and EDP2939.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Evelo Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial.

Detailed description

This study will evaluate the pharmacodynamic effects of multiple doses of EDP1815 and EDP2939 on immunological responses to keyhole limpet hemocyanin (KLH) and imiquimod (IMQ) dermal challenges in healthy volunteers. EDP1815 is an essentially non-live, specific strain of Prevotella histicola, a natural human commensal organism. EDP2939 is a pharmaceutical preparation of microbial extracellular vesicles. Four cohorts of volunteers (n=18 per cohort) will be studied using different capsule formulations and doses, administered for 60 days. Volunteers will be immunised with intramuscular KLH. Intradermal KLH re-challenge and topical IMQ challenge will commence on Day 57 with serial pharmacodynamic assessments to Day 60. Responses will be evaluated using dermal imaging (laser speckled contrast imaging; LSCI, and multi-spectral photography), as well as dermal and systemic immunological biomarkers.

Conditions

• KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	EDP1815	EDP1815 is an essentially non-viable, non-replicating pharmaceutical preparation of a single strain of Prevotella histicola, a naturally occurring human commensal microbe.
DRUG	EDP2939	EDP2939 is a pharmaceutical preparation of extracellular vesicles.
DRUG	Placebo oral capsule	Placebo.

Timeline

• Start date: 2022-06-27
• Primary completion: 2022-10-14
• Completion: 2022-10-14
• First posted: 2023-01-12
• Last updated: 2023-05-19

Locations

1 site across 1 country: Netherlands