Evaluation of the Immunopharmacology of EDP1815 and EDP2939

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Evelo Biosciences, Inc.

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 day

• Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks before start of the study

• History of Schistosomiasis.