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 randomized, double-blind, placebo-controlled, multiple ascending-dose study to evaluate the safety, tolerability and pharmacokinetics characteristics of VV261 tablets in healthy adults.
This study is a randomized, double-blind, placebo-controlled trial designed to enroll a total of 16 participants. It initially comprises two dose groups administered sequentially from the low-dose group to the high-dose group, with eight participants in each group randomly assigned to either the investigational drug or placebo. The dose escalation levels were set at 600 mg and 900 mg, administered three times daily (with an 8-hour interval) for 7.5 consecutive days, followed by a final dose on the morning of day 8, totaling 22 doses.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VV261 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VV261 600mg TID group | Drug | 6 participants receive VV261 100mg 6 tablets,three times daily,orally; 2 participants will receive placebo,orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed plasma concentration | Baseline to 72 hours after the last administration |
| Tmax | Time at which Cmax occurs | Baseline to 72 hours after the last administration |
| Ctrough | Minimum observed steady-state plasma concentration | Baseline to 72 hours after the last administration |
| AUC0-t | Area under the plasma concentration time curve from time zero to the last measurable concentration | Baseline to 72 hours after the last administration |
| AUC0-∞ | Area under the plasma concentration-time curve from time zero to infinity | Baseline to 72 hours after the last administration |
| t1/2 | Half life of elimination | Baseline to 72 hours after the last administration |
| CL/F | Apparent clearance | Baseline to 72 hours after the last administration |
| mean Resident Time | Mean Resident Time from time zero to infinity/the last | Baseline to 72 hours after the last administration |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huaqing Duan | Contact | 18061926005 | huaqing.duan@vigonvita.cn |
| Name | Affiliation | Role |
|---|---|---|
| Huan Zhou | The First Affiliated Hospital of Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230031 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| VV261 900mg TID group | Drug | 6 participants receive VV261 100mg 9 tablets,three times daily,orally; 2 participants will receive placebo,orally |
|
| Vd/F | Apparent volume of distribution during the terminal phase | Baseline to 72 hours after the last administration |
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events | Baseline to 7days after the last administration |