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This study is a single-center, randomized, double-blind, placebo-controlled, dose-escalation trial to assess the safety, tolerability, pharmacokinetics (PK) of multiple doses of VV913 in Chinese healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VV913 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VV913 4mg group | Drug | 6 participants will receive VV913 4mg orally; 2 participants will receive placebo orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events | Baseline to 6 days after the last administration |
| Cmax | maximum observed plasma 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 |
| Tmax | time at which Cmax occurs | Baseline to 72 hours after the last administration |
| t1/2 | half-life of elimination | Baseline to 72 hours after the last administration |
| Apparent Clearance Rate(CL/F) | apparent clearance | Baseline to 72 hours after the last administration |
| Vd/F | apparent volume of distribution during the terminal phase | Baseline to 72 hours after the last administration |
| λz | elimination rate constant | Baseline to 72 hours after the last administration |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| VV913 8mg group | Drug | 6 participants will receive VV913 8mg orally; 2 participants will receive placebo orally. |
|
| VV913 15mg group | Drug | 6 participants will receive VV913 15mg orally; 2 participants will receive placebo orally. |
|
| AUC0-24h | area under the plasma concentration time curve from time zero to 24h | 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 |
| Rac | Accumulation Ratio of VV913 | Baseline to 72 hours after the last administration |