Evaluation of the Immunopharmacology of EDP1815 and EDP2939

Last updated: May 18, 2023
Sponsor: Evelo Biosciences, Inc.
Overall Status: Completed

Phase

1

Condition

Inflammation

Rash

Allergy

Treatment

EDP1815

EDP2939

Placebo oral capsule

Clinical Study ID

NCT05682222
EDP1815-105
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Capable of giving signed informed consent, and willing to comply with requirements ofthe study.
  • Age 18 years to 45 years, inclusive.
  • Body mass index of 18 to 35 kg/m2, inclusive.
  • Caucasian.
  • Healthy based on medical history, physical examination, blood pressure, ECG and bloodand urine laboratory tests.

Exclusion

Key Exclusion Criteria:

  • Use of Aldara® (imiquimod cream) within 3 weeks prior to the study.
  • Has previously received Immucothel® or KLH.
  • Allergy to Alhydrogel® or Aldara® (imiquimod cream).
  • Current or recurrent skin diseases affecting the arms or back, or extensive tattoos inthese areas.
  • Previous diagnosis of psoriasis.
  • History of pathological scar formation (e.g. keloid scar).
  • History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma).
  • Significant bowel disease (e.g. inflammatory bowel disease, coeliac disease)
  • Currently has an infection or has needed antibiotics within 6 weeks before the study.
  • Current smoker of more than 5 cigarettes per day
  • Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeksbefore start of the study
  • History of Schistosomiasis.

Study Design

Total Participants: 38
Treatment Group(s): 3
Primary Treatment: EDP1815
Phase: 1
Study Start date:
June 27, 2022
Estimated Completion Date:
October 14, 2022

Study 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.

Connect with a study center

  • Centre for Human Drug Research

    Leiden, 2333 CL
    Netherlands

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.