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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 VV913 Capsules in healthy adults.
The study is designed to enroll 56 participants. The study , conducted as a double-blind study, comprise 7 dose groups with 8 participants each. Participants will be randomly assigned to receive either the VV913 Capsules or placebo in a ratio of 6:2. Dose groups are designed as 1 mg, 2 mg, 4 mg, 8 mg, 15 mg, 25 mg, and 40 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 |
|---|---|---|---|
| VV913 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VV913 1mg group | Drug | 6 participants will receive VV913 1mg orally; 2 participants will receive placebo orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | maximum observed plasma concentration | 72 hours after administration |
| Tmax | time at which Cmax occurs | 72 hours after administration |
| t1/2 | half life of elimination | 72 hours after administration |
| AUC0-t | area under the plasma concentration time curve from time zero to the last measurable concentration | 72 hours after administration |
| AUC0-∞ | area under the plasma concentration-time curve from time zero to infinity | 72 hours after administration |
| Kel | elimination rate constant | 72 hours after administration |
| Vd/F | apparent volume of distribution during the terminal phase | 72 hours after administration |
| MRT | mean residence time | 72 hours after administration |
| CL/F |
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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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| VV913 2mg group | Drug | 6 participants will receive VV913 2mg orally; 2 participants will receive placebo orally. |
|
| VV913 4mg group | Drug | 6 participants will receive VV913 4mg orally; 2 participants will receive placebo orally. |
|
| 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. |
|
| VV913 25mg group | Drug | 6 participants will receive VV913 25mg orally; 2 participants will receive placebo orally. |
|
| VV913 40mg group | Drug | 6 participants will receive VV913 40mg orally; 2 participants will receive placebo orally. |
|
apparent clearance
| 72 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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