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This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-235 in healthy adult subjects.
The first phase assesses single ascending doses of EDP-235 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.
The second phase assesses multiple ascending doses of EDP-235 or placebo for 7-days in healthy subjects.
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-235 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDP-235 SAD Cohorts | Experimental | EDP-235 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5, orally, once daily in one single administration |
|
| EDP-235 MAD Cohorts | Experimental | EDP-235 Dose 1, Dose 2 and Dose 3 orally, once daily for 7 days |
|
| EDP-235 SAD Placebo Cohorts | Placebo Comparator | Matching placebo, orally, once daily in one single administration |
|
| EDP-235 MAD Placebo Cohorts | Placebo Comparator | Matching placebo, orally, once daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-235 | Drug | Oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by adverse events | Up to 8 Days in HV SAD Cohorts | |
| Safety measured by adverse events | Up to 14 Days in HV MAD Cohorts |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-235 | Up to 5 Days in HV SAD Cohorts | |
| AUC of EDP-235 | Up to 5 Days in HV SAD Cohorts | |
| Cmax of EDP-235 |
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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 |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates, Inc., | Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722008 | EDP-235 |
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| Placebo |
| Drug |
Placebo to match EDP-235, oral administration |
|
| Up to 11 Days in HV MAD Cohorts |
| AUC of EDP-235 | Up to 11 Days in HV MAD Cohorts |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |