KLH and imiquimod induced skin inflammation in healthy volunteers Skin and Connective Tissue Diseases
Conditions
Interventions
The active drug will be EDP1815 in Cohorts 1 and 2, and EDP2939 in Cohorts 3 and 4. In all cohorts, subjects will be randomized 2:1 to receive active or placebo treatment. The study drug will be admin
on clinic visit days, the study drug will be administered at the clinic.
An unblinded statistician generates a randomization list (active:placebo = 2:1). Study drug will be dispensed by an unblinded
Sponsors
Evelo Biosciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KLH-induced immune reaction after intradermal re-challenge, measured as basal flow (laser speckle contrast imaging [LSCI]) at 24 h | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. KLH-induced immune reaction after intradermal re-challenge, measured as basal flow (LSCI) at 4 h, 48 h and 72 h 2. KLH-induced immune reaction after intradermal re-challenge, measured as flare (LSCI) at 4 h, 24 h, 48 h and 72 h 3. KLH-induced immune reaction after intradermal re-challenge, measured as erythema (multispectral imaging) at 4 h, 24 h, 48 h and 72 h 4. Specific B-cell response to KLH, measured as anti-KLH IgM and IgG at 1, 22, 36 and 57 days 5. IMQ-induced immune reaction, measured as basal flow (LSCI) at 24 h, 48 h and 72 h 6. IMQ-induced immune reaction, measured as flare (LSCI) at 24 h, 48 h and 72 h 7. IMQ-induced immune reaction, measured as erythema (multispectral imaging) at 24 h, 48 h and 72 h | — |
Countries
Netherlands
Contacts
Public ContactBoukje Eveleens Maarse
Outcome results
None listed