Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase I, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of ASC10 tablets and an open-label, crossover design to evaluate the food effect on PK of ASC10 in healthy subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASC10 | Experimental | Part 1: Participants will be randomized to receive 100 to 1600 mg ASC10 (including 6 cohorts) in an double-blind manner Part 2: Participants will be randomized to receive two single 800 mg doses (fed or fasted) |
|
| Placebo | Placebo Comparator | Part 1: Participants will be randomized to receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC10 | Drug | Part 1: Participants will be randomized to receive twice daily dosing either ASC10 or Placebo for 5.5 days, in an double-blind manner Part 2: Two single oral doses of ASC10 will be administered to participants, in an open-label manner |
| Measure | Description | Time Frame |
|---|---|---|
| Part1: Number of participants with Treatment Emergent Adverse Events (TEAEs) in multiple ascending dose (MAD) | From screening through study completion, up to 12 days | |
| Part1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs in MAD | Vital signs evaluation includes: systolic and diastolic blood pressure (BP), temperature, respiratory rate and pulse rate. | From screening through study completion, up to 12 days |
| Part1: Number of Participants With Laboratory Abnormalities in MAD | From screening through study completion, up to 12 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yunqing Qiu, Master | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38988285 | Derived | Liu J, Zhao Q, Zhai Y, Wu X, Kai J, Ruan J, Wu M, Wu M, Zhou Z, Yan Y, Wu JJ, Qiu Y. Safety, tolerability and pharmacokinetics of ASC10, a novel oral double prodrug of a broad-spectrum antiviral agent, beta-d-N4-hydroxycytidine: results from a randomized, double-blind, placebo-controlled phase 1 study in Chinese healthy subjects. Expert Opin Investig Drugs. 2024 Aug;33(8):867-876. doi: 10.1080/13543784.2024.2377318. Epub 2024 Jul 12. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Part 1: Participants will be randomized to receive twice daily dosing either ASC10 or Placebo, in an double-blind manner |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |