NCT05201690

Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV116 in Healthy Volunteers

A Randomized, Double-blinded, Placebo-controlled, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of VV116 After Multiple Ascending Doses Administered Orally to Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	VV116 200 mg Group	Drug: VV116 9 subjects will receive VV116 200 mg, orally, QD12h, 5.5 days ;
DRUG	VV116 400mg Group	Drug: VV116 9 subjects will receive VV116 400 mg, orally, QD12h, 5.5 days ;
DRUG	VV116 600mg Group	Drug: VV116 9 subjects will receive VV116 600 mg, orally, QD12h, 5.5 days ;

Timeline

• Start date: 2021-12-14
• Primary completion: 2022-01-19
• Completion: 2022-01-23
• First posted: 2022-01-21
• Last updated: 2022-02-09

Locations

1 site across 1 country: China