Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP1867 · 1 trial · 3 indications
Number of participants with AEs by seriousness and relationship to treatment
Number of participants with clinically significant change from baseline (Day 0) in laboratory values
Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
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
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)
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 7.5 x 10\^11 cells, capsules, once daily, 14 days total |
| Cohort 2 | EXPERIMENTAL | 12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 1.5 x 10\^12 cells, capsules, once daily, 14 days total |
| Cohort 3 | EXPERIMENTAL | 24 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 | EXPERIMENTAL | 24 subjects with moderate psoriasis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10\^11 cells, capsules, once daily, 56 days |
| Cohort 5 | EXPERIMENTAL | 24 subjects with mild asthma; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10\^11 cells, capsules, once daily, 56 days |
| Name | Type | Description |
|---|---|---|
| EDP1867 | DRUG | EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria |
| Placebo | DRUG | Placebo oral capsule |
Key Inclusion Criteria: 1. Age ≥ 18 years to 65 years. 2. Participant has a body mass index of ≥ 18 kg/m2 to ≤ 35 kg/m2. 3. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG monitoring at Screening and...
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