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This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDP-978 SAD Cohorts | Experimental | EDP-978 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6 and Dose 7, orally daily in one single administration |
|
| EDP-978 MAD Cohorts | Experimental | EDP-978 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily for 14 days |
|
| EDP-978 SAD Placebo Cohorts | Placebo Comparator | Matching placebo, orally, once daily in one single administration |
|
| EDP-978 MAD Placebo Cohorts | Placebo Comparator | Matching placebo, orally, once daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-978 | Drug | Oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by adverse events | Up to 8 Days in SAD Cohorts | |
| Safety measured by adverse events | Up to 28 Days in MAD Cohorts |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-978 | Up to 5 Days in SAD Cohorts | |
| AUC of EDP-978 | Up to 5 Days in SAD Cohorts | |
| Cmax of EDP-978 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enanta Pharmaceuticals, Inc | Contact | (617) 607-0800 | emartin@enanta.com |
| Name | Affiliation | Role |
|---|---|---|
| Enanta Pharmaceuticals, Inc | Enanta Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase | Recruiting | San Antonio | Texas | 78209 | United States |
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| Placebo |
| Drug |
Placebo to match EDP-978, oral administration |
|
| Up to 18 Days in MAD Cohorts |
| AUC of EDP-978 | Up to 18 Days in MAD Cohorts |
| Cmax of EDP-938 (FE) | Food effects on plasma PK parameters of EDP-978 | Up to 12 Days in FE SAD Cohort |
| AUC of EDP-938 (FE) | Food effects on plasma PK parameters of EDP-978 | Up to 12 Days in FE SAD Cohort |
| ID | Term |
|---|---|
| D000094482 | Chronic Inducible Urticaria |
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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