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This is a randomized, double-blind, placebo-controlled, single ascending-dose study to evaluate the safety, tolerability and pharmacokinetics characteristics of VV261 tablets in healthy adults.
The study is designed to enroll 58 volunteers. The pilot study is an open-labelled study where both volunteers receive 5 mg VV261 tablets. The formal study, conducted as a double-blind study, comprise 7dose groups with 8 volunteers (both sexes) each. Volunteers will be randomly assigned to receive either the VV261 tablets or placebo in a ratio of 6:2. The formal study's dose groups are designed as 20 mg, 50 mg, 150 mg, 300 mg, 500 mg, 750 mg, and 1000 mg. Based on observed tolerability and safety data or obtained pharmacokinetic data, adjustments are allowed at all dose levels in the clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VV261 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VV261 5mg group | Drug | 2 subjects will receive VV261 5mg, orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | maximum observed plasma concentration | 48 hours after administration] |
| AUC0-t | area under the plasma concentration time curve from time zero to the last measurable concentration | 48 hours after administration |
| AUC0-∞ | area under the plasma concentration-time curve from time zero to infinity | 48 hours after administration] |
| Tmax | time at which Cmax occurs | 48 hours after administration |
| t1/2 | half life of elimination | 48 hours after administration |
| Kel | elimination rate constant | 48 hours after administration |
| CLz/F | apparent clearance | 48 hours after administration |
| Vd/F | apparent volume of distribution during the terminal phase | 48 hours after administration |
| MRT |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230031 | China |
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| VV261 20mg Group |
| Drug |
6 subjects receive VV261 20mg,orally; 2 subjects will receive placebo,orally. |
|
| VV261 50mg group | Drug | 6 subjects receive VV261 50mg,orally; 2 subjects will receive placebo,orally. |
|
| VV261 100mg group | Drug | 6 subjects receive VV261 100mg,orally; 2 subjects will receive placebo,orally. |
|
| VV261 150mg group | Drug | 6 subjects receive VV261 150mg,orally; 2 subjects will receive placebo,orally. |
|
| VV261 300mg group | Drug | 6 subjects receive VV261 300mg,orally; 2 subjects will receive placebo,orally. |
|
| VV261 500mg group | Drug | 6 subjects receive VV261 500mg,orally; 2 subjects will receive placebo,orally. |
|
| VV261 750mg group | Drug | 6 subjects receive VV261 750mg,orally; 2 subjects will receive placebo,orally. |
|
| VV261 1000mg group | Drug | 6 subjects receive VV261 1000mg,orally; 2 subjects will receive placebo,orally. |
|
mean residence time
| 48 hours after administration |
| AE & SAE | Adverse event & serious adverse events | from day1 to day7 after administration |
| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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