A Phase I, randomized, double-blind, placebo-controlled, multiple-dose platform study investigating the immunopharmacology of EDP1815 and EDP2939

Evelo Biosciences0 sites38 target enrollmentJuly 1, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: KLH and imiquimod induced skin inflammation in healthy volunteers
Sponsor: Evelo Biosciences
Enrollment: 38
Status: Completed
Last Updated: last year

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38748319/ (added 24/05/2024)

Registry

who.int

Start Date

July 1, 2022

End Date

May 23, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Evelo Biosciences

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

•1\. Use of Aldara® (imiquimod cream) within 3 weeks prior to the study
•2\. Has previously received Immucothel® or KLH
•3\. Allergy to Alhydrogel® or Aldara® (imiquimod cream)
•4\. Current or recurrent skin diseases affecting the arms or back, or extensive tattoos in these areas
•5\. Previous diagnosis of psoriasis
•6\. History of pathological scar formation (e.g. keloid scar)
•7\. History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma)
•8\. Significant bowel disease (e.g. inflammatory bowel disease, coeliac disease)
•9\. Currently has an infection or has needed antibiotics within 6 weeks before the study
•10\. Current smoker of more than 5 cigarettes per day