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A single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial.
This study will evaluate the pharmacodynamic effects of multiple doses of EDP1815 and EDP2939 on immunological responses to keyhole limpet hemocyanin (KLH) and imiquimod (IMQ) dermal challenges in healthy volunteers.
EDP1815 is an essentially non-live, specific strain of Prevotella histicola, a natural human commensal organism. EDP2939 is a pharmaceutical preparation of microbial extracellular vesicles.
Four cohorts of volunteers (n=18 per cohort) will be studied using different capsule formulations and doses, administered for 60 days. Volunteers will be immunised with intramuscular KLH. Intradermal KLH re-challenge and topical IMQ challenge will commence on Day 57 with serial pharmacodynamic assessments to Day 60. Responses will be evaluated using dermal imaging (laser speckled contrast imaging; LSCI, and multi-spectral photography), as well as dermal and systemic immunological biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other | EDP1815 or placebo in capsule A, dosed for 60 days. Randomization is 2:1 active:placebo. |
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| Cohort 2 | Other | EDP1815 or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo. |
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| Cohort 3 | Other | EDP2939 lower dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo. |
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| Cohort 4 | Other | EDP2939 higher dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP1815 | Drug | EDP1815 is an essentially non-viable, non-replicating pharmaceutical preparation of a single strain of Prevotella histicola, a naturally occurring human commensal microbe. |
| Measure | Description | Time Frame |
|---|---|---|
| KLH-induced immune reaction. | This will be measured as basal flow (arbitrary units, AU) by LSCI. | At 24 hours after Day 57 intradermal re-challenge. |
| Measure | Description | Time Frame |
|---|---|---|
| KLH-induced immune reaction - basal flow. | This will be measured as basal flow (AU) by LSCI. | At 4 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge. |
| KLH-induced immune reaction - flare. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Leiden | 2333 CL | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38748319 | Derived | Eveleens Maarse BC, Ronner MN, Jansen MAA, Niemeyer-van der Kolk T, In 't Veld AE, Klaassen ES, Ahmad S, Itano A, McHale D, Moerland M. Immunomodulating effects of the single bacterial strain therapy EDP1815 on innate and adaptive immune challenge responses - a randomized, placebo-controlled clinical trial. Immunol Res. 2024 Aug;72(4):776-787. doi: 10.1007/s12026-024-09484-7. Epub 2024 May 15. |
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This is a single-center, randomized, double-blind, placebo-controlled, platform trial to evaluate the effects of EDP1815 and EDP2939 on the systemic immune system, using intradermal KLH and topical IMQ skin challenges. A total of at least 72 healthy volunteers will be divided into 4 cohorts.
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Double-blind
| EDP2939 | Drug | EDP2939 is a pharmaceutical preparation of extracellular vesicles. |
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| Placebo oral capsule | Drug | Placebo. |
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This will be measured as flare (AU) by LSCI.
| At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge. |
| KLH-induced immune reaction - erythema. | This will be measured as erythema (AU) by multispectral imaging. | At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge. |
| IMQ-induced immune reaction - basal flow. | This will be measured as basal flow (AU) by LSCI. | At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge. |
| IMQ-induced immune reaction - flare. | This will be measured as flare (AU) by LSCI. | At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge. |
| IMQ-induced immune reaction - erythema. | This will be measured as erythema (AU) by multispectral imaging. | At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge. |
| Specific B-cell response to KLH. | This will be measured as anti-KLH IgM and IgG (% of baseline concentration). | After Day 57 intradermal re-challenge. |
| Serious adverse event (SAE) and adverse event (AE) incidents. | SAEs and AEs assessed by: type, frequency, severity and treatment-relatedness of the event. | Up to Day 74. |
| Number of participants with blood laboratory safety abnormalities. | Up to Day 74. |
| Number of participants with urinary laboratory safety abnormalities. | Up to Day 74. |
| Number of participants with electrocardiogram (ECG) abnormalities. | Up to Day 74. |
| Number of participants with vital signs abnormalities. | Up to Day 74. |
| Number of participants with physical examination abnormalities. | Up to Day 74. |