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This is a randomized, double-blinded, placebo-controlled, single-center phase I clinical trial. The objective of this study is to evaluate the safety, tolerability, pharmacokinetic profiles of VV116 tablets after multiple ascending doses administered orally to Chinese healthy volunteers.
Multiple-dose ascending design is used in the trial, VV116/Placebo is administered sequentially from low-dose to high-dose and each subject can only orally receive one dose level. There are 3 dose groups (200mg, 400mg, 600mg), investigational product is orally administrated BID for 5.5 days, the last dose is taken in D6 morning. When 7th day visit after last dose (D12) is completed for previous dose group, investigator and sponsor will evaluate the safety and determine whether the next dose group can be started. 12 subjects will be enrolled in each dose group and the ratio of investigational product to placebo is 3:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VV116 200 mg Group | Experimental | VV116 200 mg Group |
|
| VV116 400 mg Group | Experimental | VV116 400 mg Group |
|
| VV116 600 mg Group | Experimental | VV116 600 mg Group |
|
| Placebo | Placebo Comparator | VV116 Matching placebo tablets; Multiple doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VV116 200 mg Group | Drug | Drug: VV116 9 subjects will receive VV116 200 mg, orally, QD12h, 5.5 days ; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent treatment-related adverse event(s) | Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs | Dosing through follow-up call (7 days after last dose of investigational product) |
| Number of participants with laboratory test findings of potential clinical importance | Dosing through follow-up call (7 days after last dose of investigational product) | |
| Number of participants with vital signs findings of potential clinical importance | Dosing through follow-up call (7 days after last dose of investigational product) | |
| Number of participants with ECG findings of potential clinical importance | Number of subjects with change from baseline in electrocardiogram (ECG) parameters | Dosing through follow-up call (7 days after last dose of investigational product) |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to reach maximum observed plasma concentration | Calculated using concentration data collected from predose to 48 hours postdose |
| Cmax | Maximum observed plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gangyi Liu | Shanghai Xuhui Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| C000722705 | GS-621763 |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| VV116 400mg Group | Drug | Drug: VV116 9 subjects will receive VV116 400 mg, orally, QD12h, 5.5 days ; |
|
| VV116 600mg Group | Drug | Drug: VV116 9 subjects will receive VV116 600 mg, orally, QD12h, 5.5 days ; |
|
| Calculated using concentration data collected from predose to 48 hours postdose |
| T1/2 | Terminal half life | Calculated using concentration data collected from predose to 48 hours postdose |
| AUC0-T | Calculated using concentration data collected from predose to 48 hours postdose | Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration. |
| AUC0-∞ | Area under the plasma concentration-time curve from time 0 extrapolated to infinity | Calculated using concentration data collected from predose to 48 hours postdose |