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This study has been cancelled due to business reasons.
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This is a phase Ib, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, efficacy and pharmacokinetics of ASC10 tablets in mild or moderate COVID-19 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASC10 | Experimental | Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days |
|
| Placebo | Placebo Comparator | Participants will be randomized to receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC10 | Drug | Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses | From Day 0 to Study Completion, up to 32 days | |
| PK parameters for ASC10, GLC01-700 (molnupiravir) and ASC10-A in plasma as AUC0-12h | From Day 1 to Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms | From Day 1 to Study Completion, up to 32 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| Aga Clinical Trials |
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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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| Placebo |
| Drug |
Participants will be randomized to receive placebo |
|
| Hialeah |
| Florida |
| 33012 |
| United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |