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Recruiting
NCT05682222
Evaluation of the Immunopharmacology of EDP1815 and EDP2939
Conditions: KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 72
Sponsor: Evelo Biosciences, Inc.
Location: Netherlands
Summary
A single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial.
Eligibility Criteria
Key Inclusion Criteria:Capable of giving signed informed consent, and willing to comply with requirements of the 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 blood and urine laboratory tests.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 in these 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 dayTanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks before start of the studyHistory of Schistosomiasis.
Source: ClinicalTrials.gov (NCT05682222). StuddyBuddy aggregates publicly available trial information.