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

Evelo Biosciences0 个研究点目标入组 38 人开始时间: 2022年7月1日最近更新: 2024年6月3日

适应症

试验速览

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

•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
•11. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks before the start of the study
•12. History of schistosomiasis (infection with Schistosoma parasite)

发起方

Evelo Biosciences