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This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-323 in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDP-323 SAD Cohorts | Experimental | EDP-323 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6, orally, once daily in one single administration |
|
| EDP-323 MAD Cohorts | Experimental | EDP-323 Dose 1, Dose 2, Dose 3 and Dose 4 orally, once daily for 7 days |
|
| EDP-323 SAD Placebo Cohorts | Placebo Comparator | Matching placebo, orally, once daily in one single administration |
|
| EDP-323 MAD Placebo Cohorts | Placebo Comparator | Matching placebo, orally, once daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-323 | 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 14 Days in MAD Cohorts |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-323 | Up to 5 Days in SAD Cohorts | |
| AUC of EDP-323 | Up to 5 Days in SAD Cohorts | |
| Cmax of EDP-323 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enanta Pharmaceuticals, Inc | Enanta Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON, plc. | Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| Placebo |
| Drug |
Placebo to match EDP-323, oral administration |
|
| Up to 11 Days in MAD Cohorts |
| AUC of EDP-323 | Up to 11 Days in MAD Cohorts |
| D014777 | Virus Diseases |
| D007239 | Infections |