Evaluation of the Immunopharmacology of EDP1815 and EDP2939

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2022-10-14

Brief Summary

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

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Detailed Description

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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.

Conditions

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KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double-blind

Study Groups

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Cohort 1

EDP1815 or placebo in capsule A, dosed for 60 days. Randomization is 2:1 active:placebo.

Group Type OTHER

EDP1815

Intervention Type DRUG

EDP1815 is an essentially non-viable, non-replicating pharmaceutical preparation of a single strain of Prevotella histicola, a naturally occurring human commensal microbe.

Placebo oral capsule

Intervention Type DRUG

Placebo.

Cohort 2

EDP1815 or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.

Group Type OTHER

EDP1815

Intervention Type DRUG

EDP1815 is an essentially non-viable, non-replicating pharmaceutical preparation of a single strain of Prevotella histicola, a naturally occurring human commensal microbe.

Placebo oral capsule

Intervention Type DRUG

Placebo.

Cohort 3

EDP2939 lower dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.

Group Type OTHER

EDP2939

Intervention Type DRUG

EDP2939 is a pharmaceutical preparation of extracellular vesicles.

Placebo oral capsule

Intervention Type DRUG

Placebo.

Cohort 4

EDP2939 higher dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.

Group Type OTHER

EDP2939

Intervention Type DRUG

EDP2939 is a pharmaceutical preparation of extracellular vesicles.

Placebo oral capsule

Intervention Type DRUG

Placebo.

Interventions

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EDP1815

EDP1815 is an essentially non-viable, non-replicating pharmaceutical preparation of a single strain of Prevotella histicola, a naturally occurring human commensal microbe.

Intervention Type DRUG

EDP2939

EDP2939 is a pharmaceutical preparation of extracellular vesicles.

Intervention Type DRUG

Placebo oral capsule

Placebo.

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes