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This trial is a multi dose, randomized, double-blind, placebo-controlled, single center Phase I clinical study. The purpose of this study is to evaluate the safety, tolerability, and PK characteristics of Deuteromide Hydrobromide for Suspension administered multiple times in healthy volunteers.
Two groups are initially set up, starting from Group 1 and progressing sequentially to Group 2. After all volunteers in the first group (900 mg BID group) complete the safety follow-up on the 4th day after the last dose (i.e. D10), the safety information and PK data will be reviewed jointly by the researchers and sponsors before the second group of volunteers starting administration. The preferred dose for the second group is 900 mg TID, and if there are safety risks found after the Group 1 study, it will be adjusted to 1200 mg BID or other appropriate dosage and frequency.
A total of 24 volunteers are planned to be enrolled, with 12 volunteers in each group. The trial drug and placebo will be allocated in a 3:1 ratio, with 9 volunteers in each group receiving the trial drug and 3 volunteers receiving placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deuremidevir Hydrobromide for Suspension 900mg group, twice a day | Experimental | 9 subjects will receive Deuremidevir Hydrobromide for Suspension 900mg, orally, Q12h, 5.5 days; 3 subjects will receive Deuremidevir Hydrobromide for Suspension Placebo 900mg, orally, Q12h, 5.5 days. |
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| Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day | Experimental | 9 subjects will receive Deuremidevir Hydrobromide for Suspension 900mg, orally, Q8h, 5.5 days; 3 subjects will receive Deuremidevir Hydrobromide for Suspension Placebo 900mg, orally, Q8h, 5.5 days. |
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| Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day | Experimental | 9 subjects will receive Deuremidevir Hydrobromide for Suspension 1200mg, orally, Q12h, 5.5 days; 3 subjects will receive Deuremidevir Hydrobromide for Suspension Placebo 1200mg, orally, Q12h, 5.5 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deuremidevir Hydrobromide for Suspension | Drug | Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, twice a day Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day Experimental: Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events | From Day1 to Day10 after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | maximum observed plasma concentration | 168 hours after administration |
| Tmax | time at which Cmax occurs | 168 hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaojie Wu | Hushan Hospital Fudan university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hushan Hospital Fudan university | Shanghai | Shanghai Municipality | 201900 | China |
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| Deuremidevir Hydrobromide for Suspension Placebo | Drug | Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, twice a day Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day Experimental: Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day |
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| AUC0- t | area under the plasma concentration time curve from time zero to the last quantifiable concentration | 168 hours after administration |
| AUC0-∞ | area under the plasma concentration time curve from time zero to infinity | 168 hours after administration |
| t1/2 | terminal half life | 168 hours after administration |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013535 | Suspensions |
| C000722705 | GS-621763 |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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