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

NCT05227768 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-06-01

No results posted yet for this study

Summary

The study consists of 5 dose groups, starting at 25 mg, 6 subjects in 25 mg group, and 8 subjects in each other group (male or female), randomly assigned to study drug or placebo group to evaluate the safety, tolerability and PK characteristics. The subject number of single dose group may increase or decrease depending on the safety and PK data obtained. The dose levels are planned at 25 mg, 200 mg, 400 mg, 800 mg and 1200 mg. Based on observed tolerability and safety data or obtained PK data, adjustments are allowed at all dose levels in the clinical trial.

Conditions

  • Healthy Subjects

Interventions

DRUG

VV116 25mg Group

4 subjects will receive VV116 25mg,orally; 2 subjects will receive placebo,orally.

DRUG

VV116 200mg Group

6 subjects will receive VV116 200mg,orally; 2 subjects will receive placebo,orally.

DRUG

VV116 400mg Group

6 subjects will receive VV116 400mg,orally; 2 subjects will receive placebo,orally.

DRUG

VV116 800mg Group

6 subjects will receive VV116 800mg,orally; 2 subjects will receive placebo,orally.

DRUG

VV116 1200mg Group

6 subjects will receive VV116 1200mg,orally; 2 subjects will receive placebo,orally.

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
2021-11-11
Primary Completion
2022-01-13
Completion
2022-01-13

Countries

  • China

Study Locations

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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 NCT05227768 on ClinicalTrials.gov