A Ph1a/1b, First in Human, Participant and Investigator-blind Sponsor-unblinded Randomized Placebo-controlled Multiple Dose Study of EDP1867 in Healthy Volunteers & Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Safety and tolerability measured through Adverse Events (AEs)
研究概览
简要总结
This Phase 1 study will investigate the safety and tolerability of EDP1867 in healthy volunteers, participants with atopic dermatitis, and, optionally, in participants with psoriasis and/or asthma.
详细描述
This is a phase 1a/1b, first in human, participant and investigator-blind sponsor-unblinded randomized placebo-controlled multiple dose study of EDP1867 in healthy volunteers and participants with moderate atopic dermatitis and, optionally, moderate psoriasis, and/or mild asthma. This study has been designed to investigate the clinical safety and tolerability of EDP1867 in healthy volunteers, participants with atopic dermatitis, and, optionally, in participants with psoriasis and/or asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years to 65 years.
- •Participant has a body mass index of ≥ 18 kg/m2 to ≤ 35 kg/m
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG monitoring at Screening and at Baseline.
- •Additional Inclusion Criteria for Participants with Moderate Atopic Dermatitis
- •Participant has moderate atopic dermatitis with a minimum of 5% and a maximum of 40% BSA involvement, and an IGA score of 2 or
- •Participant has had a confirmed diagnosis of atopic dermatitis for at least 6 months.
- •All participants must be using an emollient and should continue to use this once daily (or more, as needed) for at least 14 days prior to randomisation, and must continue this treatment once daily (or more, as needed) throughout the study.
- •Additional Inclusion Criteria for Participants with Moderate Psoriasis
- •Participant has moderate plaque psoriasis with plaque covering BSA of ≥3% and ≤10% and meets both of the following additional criteria:
- •PASI score of ≥6 and ≤15, and
- •PGA score of 2 or
- •Participant has a confirmed diagnosis of plaque psoriasis for at least 6 months.
- •Additional Inclusion Criteria for Participants with Mild Asthma
- •Participant has a diagnosis of stable asthma for at least six months
- •FeNO of ≥40ppb.
- •FEV1 ≥70% of predicted normal.
排除标准
- •Participant has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study (non-live vaccines are permitted).
- •Participant requires treatment with an anti-inflammatory drug during the study period.
- •Participant has an active infection (e.g. sepsis, pneumonia, abscess) or has had an infection requiring antibiotic treatment within 6 weeks prior to study intervention administration.
- •Participant has renal or liver impairment
- •Participant has active neoplastic disease or history of neoplastic disease within 5 years of Screening
- •Participant has undergone major surgery within 4 weeks prior to Screening.
- •Any known cardiac abnormality
- •Participant has a known history of human immunodeficiency virus (HIV)
- •Known, active hepatitis A, hepatitis B (HBV), or hepatitis C (HCV) infection
- •Participant with any type of GI tract disease
- •Participants with a history of any serious psychiatric condition; or on therapy for any psychiatric condition
- •The participant has taken any over-the-counter (OTC) or prescription medication, within 14 days prior to baseline (Day -1); or anticipates an inability to abstain from these products for the duration of the study period
- •The participant has a significant history of drug abuse or regular use of illicit drugs or a history of alcohol abuse within 1 year prior to Screening or has tested positive for drugs of abuse or alcohol at Screening or at baseline.
- •The participant has had an acute, clinically significant illness within 30 days prior to the first dose of study intervention.
- •Additional Exclusion Criteria for Participants with Atopic Dermatitis
- •Participant is receiving systemic immunosuppressive or non-biologic atopic dermatitis therapy or has received such therapy within 4 weeks prior to Screening.
- •Participant has received treatment with biologic agents within 12 months prior to first dose.
- •Participant continues to use topical medications, other than emollients, that could affect atopic dermatitis 2 weeks prior to the start of dosing.
- •Participant intends to continue to use sunbeds and/or increase their sun exposure significantly from their normal lifestyle
- •Additional Exclusion Criteria for Participants with Psoriasis
- •Psoriasis restricted to scalp, palm, and/or soles only.
- •Non-plaque type of psoriasis
- •Participant is receiving systemic immunosuppressive or nonbiologic psoriasis therapy or has received such therapy within 4 weeks prior to Screening
- •Participant has received treatment with biologic agents within 12 months prior to first dose.
- •Participant continues to use topical medications that could affect psoriasis within 2 weeks prior to the start of dosing
- •Participant intends to continue to use sunbeds and/or increase their sun exposure significantly from their normal lifestyle
- •Additional Exclusion Criteria for Participants with Asthma
- •History of life-threatening asthma, or a visit to the emergency department for asthma in the 6 months prior to screening, or exacerbation requiring oral corticosteroids within the previous 3 months.
- •Smoker or nicotine user within the 3 months prior to screening; or a previous smoker with a greater than 10 pack year history.
- •Other significant non-reversible pulmonary disease
- •Use of the following medicines within the specified time-frame prior to screening:
- •Long-acting inhaled β2-agonists: 8 weeks. Note: short-acting inhaled β2-agonists are permitted as required.
- •Anti-IgE therapy: 6 months
- •Inhaled corticosteroids: 8 weeks
- •Oral or Injected corticosteroids: 8 weeks
- •Intranasal or topical steroids: 4 weeks
- •Leukotriene antagonists: 2 weeks
- •Long-acting muscarinic antagonist: 8 weeks
- •Xanthines (excluding caffeine), anticholinergics, cromoglycates: 1 week.
研究组 & 干预措施
Cohort 4
24 subjects with moderate psoriasis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days
干预措施: Placebo (Drug)
Cohort 1
12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 7.5 x 10^11 cells, capsules, once daily, 14 days total
干预措施: EDP1867 (Drug)
Cohort 1
12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 7.5 x 10^11 cells, capsules, once daily, 14 days total
干预措施: Placebo (Drug)
Cohort 2
12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 1.5 x 10^12 cells, capsules, once daily, 14 days total
干预措施: EDP1867 (Drug)
Cohort 2
12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 1.5 x 10^12 cells, capsules, once daily, 14 days total
干预措施: Placebo (Drug)
Cohort 3
24 subjects with moderate atopic dermatitis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days
干预措施: EDP1867 (Drug)
Cohort 3
24 subjects with moderate atopic dermatitis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days
干预措施: Placebo (Drug)
Cohort 4
24 subjects with moderate psoriasis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days
干预措施: EDP1867 (Drug)
Cohort 5
24 subjects with mild asthma; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days
干预措施: EDP1867 (Drug)
Cohort 5
24 subjects with mild asthma; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability measured through Adverse Events (AEs)
时间窗: Day 1 to Day 70
Number of participants with AEs by seriousness and relationship to treatment
Safety and tolerability measured through lab measurements
时间窗: Day 1 to Day 70
Number of participants with clinically significant change from baseline (Day 0) in laboratory values
Safety and tolerability measured through ECG
时间窗: Day 1 to Day 70
Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
Safety and tolerability measured through physical examination
时间窗: Day 1 to Day 70
Physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, oral cavity, GI and neurological systems. Height and weight will also be measured and recorded. Number of participants with clinically relevant changes from baseline (Day 0) physical examination parameters
Safety and tolerability measured through vital signs
时间窗: Day 1 to Day 70
Blood pressure, pulse rate, respiratory rate, oxygen saturations and temperature will be assessed. Number of participants with clinically relevant changes in vital signs from baseline (Day 0)
次要结局
- Change in IGA x BSA(Day 1 to Day 70)
- Change in POEM score(Day 1 to Day 70)
- Change in Pruritis NRS average itch score(Day 1 to Day 70)
- Change in SCORAD score(Day 1 to Day 70)
- Percentage change in SCORAD score(Day 1 to Day 70)
- Percentage change in EASI score(Day 1 to Day 70)
- Percentage change in IGA x BSA(Day 1 to Day 70)
- Change in PASI score(Day 1 to Day 70)
- Change in LSS(Day 1 to Day 70)
- Percentage change in FEV1(Day 1 to Day 70)
- Change in FVC(Day 1 to Day 70)
- Percentage change in BSA(Day 1 to Day 70)
- Change in DLQI score(Day 1 to Day 70)
- Achievement of EASI-50(Day 1 to Day 70)
- Percentage change in PASI score(Day 1 to Day 70)
- Change in DLQI(Day 1 to Day 70)
- Change in BSA(Day 1 to Day 70)
- Change in Pruritis NRS worst itch score(Day 1 to Day 70)
- Percentage change in PGA x BSA(Day 1 to Day 70)
- Percentage change in FeNO(Day 1 to Day 70)
- Percentage change in FEV1/FVC ratio(Day 1 to Day 70)
- Occurrence of any exacerbation(Day 1 to Day 56)
- Change in FEV1(Day 1 to Day 70)
- Change in PEF(Day 1 to Day 70)
- Change in EASI score(Day 1 to Day 70)
- Achievement of PASI-50(Day 1 to Day 70)
- Achievement of PGA of 0 or 1(Day 1 to Day 70)
- Change in number of exacerbations(Day 1 to Day 56)
- Achievement of EASI-75(Day 1 to Day 70)
- Achievement of IGA 0 or 1(Day 1 to Day 70)
- Change in PGA x BSA(Day 1 to Day 70)
- Achievement of PASI-75(Day 1 to Day 70)
- Change in FeNO(Day 1 to Day 70)
- Percentage change in FVC(Day 1 to Day 70)
- Change in FEV1/FVC ratio(Day 1 to Day 70)
- Percentage change in PEF(Day 1 to Day 70)
- Use of any SABA medication(Day 1 to Day 56)
- Number of puffs of SABA medication(Day 1 to Day 56)