A Phase 1a/1b Randomized Double-blind Placebo-controlled Single and Multiple Ascending Dose Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- Safety and tolerability measured through Adverse Events (AEs)
研究概览
简要总结
Evelo will investigate the safety and tolerability of EDP1066 and its potential to be a medicinal product in healthy volunteers and individuals with mild to moderate psoriasis and atopic dermatitis.
详细描述
This will be a randomized, double-blind, placebo-controlled clinical study with dose escalations to assess safety, tolerability, and pharmacodynamic effect of EDP1066. Since this clinical study is the first study in humans, the participants will be healthy volunteers or subjects with mild to moderate psoriasis or atopic dermatitis who are otherwise well. Investigation of EDP1066 in this patient population provides an opportunity to gain pharmacodynamic information using a range of tissue biopsies and composite clinical endpoints.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant has a body mass index of ≥ 18 kg/m2 to ≤ 35 kg/m2 at Screening.
- •Healthy Volunteers:
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- •Mild to moderate psoriasis:
- •Participant has had a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving ≤ 5% of body surface area (BSA) (excluding the scalp).
- •Participant has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy.
- •Mild to moderate atopic dermatitis:
- •Mild to moderate atopic dermatitis with a minimum of 3% to a maximum of 15% BSA involvement.
- •Participant has had a confirmed diagnosis of mild to moderate atopic dermatitis for at least 6 months IGA score of 2 or
- •Participant has a minimum of 2 atopic dermatitis lesions with at least 1 in a site suitable for biopsy.
排除标准
- •Female participant who is pregnant, or plans to become pregnant during the study, or breastfeeding, or sexually active with childbearing potential who is not using a medically accepted birth control method.
- •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.
- •Participant has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to study intervention administration.
- •Participant requires treatment with an anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic (maximum of 2 grams/day in any 24 hour period).
- •Participant has an active infection (e.g. sepsis, pneumonia, abscess) or has had an infection requiring antibiotic treatment within 6 weeks prior to Investigational Medicinal Product (IMP) administration. When in doubt, the investigator should confer with the Sponsor study physician.
- •Participant has renal or liver impairment, defined as:
- •a. For healthy volunteers: i. For women, serum creatinine level ≥ 125 μmol/L; for men, ≥ 135 μmol/L, or ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 1.5 x upper limit of normal (ULN), or iii. Alkaline phosphatase (ALP) and/or bilirubin > 1.5 x ULN b. For participants with mild to moderate atopic dermatitis or psoriasis: i. For women, serum creatinine level ≥ 125 μmol/L; for men, ≥ 135 μmol/L, or ii. ALT or AST > 2 x ULN and/or bilirubin > 1.5 x ULN
研究组 & 干预措施
Cohort 9
up to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.
Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days
干预措施: Placebo oral capsule (Drug)
Cohort 1
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 66 mg, capsule, once daily, 15 days
干预措施: EDP1066 (Other)
Cohort 1
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 66 mg, capsule, once daily, 15 days
干预措施: Placebo oral capsule (Drug)
Cohort 2
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 15 days
干预措施: EDP1066 (Other)
Cohort 2
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 15 days
干预措施: Placebo oral capsule (Drug)
Cohort 3
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 15 days
干预措施: EDP1066 (Other)
Cohort 3
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 15 days
干预措施: Placebo oral capsule (Drug)
Cohort 4
12 subjects with mild to moderate psoriasis; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 29 days
干预措施: EDP1066 (Other)
Cohort 4
12 subjects with mild to moderate psoriasis; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 29 days
干预措施: Placebo oral capsule (Drug)
Cohort 5
24 subjects with mild to moderate psoriasis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days
干预措施: EDP1066 (Other)
Cohort 5
24 subjects with mild to moderate psoriasis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days
干预措施: Placebo oral capsule (Drug)
Cohort 6
up to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.
Dose=up to a maximum of 660 mg, capsule, once daily, 29 days
干预措施: EDP1066 (Other)
Cohort 6
up to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.
Dose=up to a maximum of 660 mg, capsule, once daily, 29 days
干预措施: Placebo oral capsule (Drug)
Cohort 7
up to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.
Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days
干预措施: EDP1066 (Other)
Cohort 7
up to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.
Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days
干预措施: Placebo oral capsule (Drug)
Cohort 8
up to 24 subjects with mild to moderate psoriasis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3g, capsule, once daily, 29 days
干预措施: EDP1066 (Other)
Cohort 8
up to 24 subjects with mild to moderate psoriasis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3g, capsule, once daily, 29 days
干预措施: Placebo oral capsule (Drug)
Cohort 9
up to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.
Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days
干预措施: EDP1066 (Other)
结局指标
主要结局
Safety and tolerability measured through Adverse Events (AEs)
时间窗: Day 1 to Day 60
Number of participants with AEs by seriousness and relationship to treatment
Safety and tolerability measured through lab measurements
时间窗: Day 0 to Day 60
Number of participants with clinically significant change from baseline (Day 0) in laboratory values
Safety and tolerability measured through ECG
时间窗: Day 0 to Day 60
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 60
Physical examination of stool samples based on the Bristol Stool Scale (Types 3 and 4 are ideal stool): Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (easy to pass); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces, entirely liquid
GI safety measurement through biomarker analysis
时间窗: Day 1 to Day 60
GI safety measurement through fecal calprotectin analysis
次要结局
- Clinical improvement in subjects with mild to moderate psoriasis(Day 0 to Day 60)
- Clinical improvement in subjects with mild to moderate atopic dermatitis(Day 0 to Day 60)