A phase 1, randomized, double-blind, placebo-controlled, multiple dose platform study investigating the immunopharmacology of EDP1815 and EDP2939
- Conditions
- Autoimmune disease10003816
- Registration Number
- NL-OMON51644
- Lead Sponsor
- Evelo Biosciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
1. Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in
this protocol. Obtained prior to any screening procedures and in accordance
with national, local, institutional guidelines.
2. Age >= 18 years to 45 years, inclusive.
3. Participant has a body mass index of >= 18 kg/m2 to <= 35 kg/m2 at Screening.
6. The participant has clinical laboratory evaluations (including clinical
chemistry, haematology, and complete urine analysis) within the reference range
for the testing laboratory, unless the results are deemed not to be clinically
significant by the investigator (1 repeat test is permitted).
7. Fitzpatrick skin type I-III (Caucasian).
8. Participants who are overtly healthy as determined by medical evaluation
including medical history, vital signs, physical examination, laboratory tests
and ECGs at Screening and on Day -1.
9. The participant has used Aldara® (imiquimod cream) within 3 weeks prior to
the baseline visit or plans to use it during the course of the study.
10. Previous known exposure to Immucothel® or KLH.
12. The participant has a history of hypersensitivity or allergies to
Prevotella (or Prevotella containing probiotics) including any associated
excipients for EDP1815 or EDP2939, or has a history of hypersensitivity or
allergies to placebo capsule/powder (magnesium stearate, microcrystalline
cellulose, colloidal silicon dioxide, hydroxypropylmethylcellulose, or
mannitol) or to the hard capsule shells (hydroxylpropylmethylcellulose and
titanium dioxide), or has a known allergy against Alhydrogel®, or has a known
allergy against Aldara® (imiquimod cream).
16. The participant has any current and / or recurrent pathologically,
clinically significant skin condition at the treatment area (i.e., atopic
dermatitis), including tattoos. Treatment area includes the forearms and back.
19. History of pathological scar formation (keloid, hypertrophic scar) or
keloids or surgical scars in the target treatment area that in the opinion of
the investigator, would limit or interfere with dosing and/or measurement in
the trial.
20. Diagnosed with psoriasis.
21. History of skin cancer (basal cell carcinoma, squamous cell carcinoma,
melanoma).
22. Tanning due to sunbathing, excessive sun exposure or a tanning booth within
3 weeks before start of treatment (Day 1) and for the duration of the study.
23. History of Schistosomiasis (infection with Schistosoma parasite).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• KLH-induced immune reaction, after intradermal re-challenge, measured as<br /><br>basal flow (LSCI) at 24 hours (h).</p><br>
- Secondary Outcome Measures
Name Time Method