Study in Healthy Participants and Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma
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
1 other identifier
interventional
52
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2021
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 23, 2021
CompletedFirst Submitted
Initial submission to the registry
April 15, 2021
CompletedFirst Posted
Study publicly available on registry
June 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedOctober 7, 2022
March 1, 2022
1 year
April 15, 2021
October 6, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Safety and tolerability measured through Adverse Events (AEs)
Number of participants with AEs by seriousness and relationship to treatment
Day 1 to Day 70
Safety and tolerability measured through lab measurements
Number of participants with clinically significant change from baseline (Day 0) in laboratory values
Day 1 to Day 70
Safety and tolerability measured through ECG
Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
Day 1 to Day 70
Safety and tolerability measured through physical examination
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
Day 1 to Day 70
Safety and tolerability measured through vital signs
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)
Day 1 to Day 70
Secondary Outcomes (40)
Change in EASI score
Day 1 to Day 70
Percentage change in EASI 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
Change in BSA
Day 1 to Day 70
- +35 more secondary outcomes
Study Arms (5)
Cohort 1
EXPERIMENTAL12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 7.5 x 10\^11 cells, capsules, once daily, 14 days total
Cohort 2
EXPERIMENTAL12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 1.5 x 10\^12 cells, capsules, once daily, 14 days total
Cohort 3
EXPERIMENTAL24 subjects with moderate atopic dermatitis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10\^11 cells, capsules, once daily, 56 days
Cohort 4
EXPERIMENTAL24 subjects with moderate psoriasis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10\^11 cells, capsules, once daily, 56 days
Cohort 5
EXPERIMENTAL24 subjects with mild asthma; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10\^11 cells, capsules, once daily, 56 days
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years to 65 years.
- Participant has a body mass index of ≥ 18 kg/m2 to ≤ 35 kg/m2.
- 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.
- Participant has moderate atopic dermatitis with a minimum of 5% and a maximum of 40% BSA involvement, and an IGA score of 2 or 3.
- 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.
- 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 3.
- Participant has a confirmed diagnosis of plaque psoriasis for at least 6 months.
- Participant has a diagnosis of stable asthma for at least six months
- FeNO of ≥40ppb.
- FEV1 ≥70% of predicted normal.
You may not qualify if:
- 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.
- Participant is receiving systemic immunosuppressive or non-biologic atopic dermatitis therapy or has received such therapy within 4 weeks prior to Screening.
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
MAC Clinical Research Manchester
Manchester, Greater Manchester, M13 9NQ, United Kingdom
Medicines Evaluation Unit (MEU)
Manchester, Greater Manchester, M23 9QZ, United Kingdom
MAC Clinical Research
Blackpool, Lancashire, FY2 0JH, United Kingdom
MAC Clinical Research
Liverpool, Merseyside, L34 1BH, United Kingdom
MAC Clinical Research
Cannock, South Staffordshire, WS11 0BN, United Kingdom
MAC Clinical Research
Stockton-on-Tees, Teeside, TS17 6EW, United Kingdom
MAC Clinical Research
Leeds, West Yorkshire, LS10 1DU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pui Man Leung, MBChB MRCP FFPM DPM
MAC Clinical Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2021
First Posted
June 15, 2021
Study Start
February 23, 2021
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
October 7, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share