A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Dose Platform Study Investigating the Immunopharmacology of EDP1815 and EDP2939.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- KLH-induced immune reaction.
研究概览
简要总结
A single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort 1
EDP1815 or placebo in capsule A, dosed for 60 days. Randomization is 2:1 active:placebo.
干预措施: EDP1815 (Drug)
Cohort 1
EDP1815 or placebo in capsule A, dosed for 60 days. Randomization is 2:1 active:placebo.
干预措施: Placebo oral capsule (Drug)
Cohort 2
EDP1815 or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.
干预措施: EDP1815 (Drug)
Cohort 2
EDP1815 or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.
干预措施: Placebo oral capsule (Drug)
Cohort 3
EDP2939 lower dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.
干预措施: EDP2939 (Drug)
Cohort 3
EDP2939 lower dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.
干预措施: Placebo oral capsule (Drug)
Cohort 4
EDP2939 higher dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.
干预措施: EDP2939 (Drug)
Cohort 4
EDP2939 higher dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
KLH-induced immune reaction.
时间窗: At 24 hours after Day 57 intradermal re-challenge.
This will be measured as basal flow (arbitrary units, AU) by LSCI.
次要结局
- KLH-induced immune reaction - erythema.(At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.)
- IMQ-induced immune reaction - basal flow.(At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.)
- Specific B-cell response to KLH.(After Day 57 intradermal re-challenge.)
- KLH-induced immune reaction - basal flow.(At 4 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.)
- Serious adverse event (SAE) and adverse event (AE) incidents.(Up to Day 74.)
- KLH-induced immune reaction - flare.(At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.)
- IMQ-induced immune reaction - flare.(At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.)
- IMQ-induced immune reaction - erythema.(At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.)
- 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.)