MedTrace Logo

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

NCT05201690 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-02-09

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

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 ;

Sponsors & Collaborators

  • Vigonvita Life Sciences

    lead INDUSTRY

Principal Investigators

  • Gangyi Liu · Shanghai Xuhui Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-14
Primary Completion
2022-01-19
Completion
2022-01-23

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05201690 on ClinicalTrials.gov