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Pharmacokinetics and Pharmacodynamics Clinical Study of VC005 Tablets in Healthy Subjects

NCT05138770 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-09-02

No results posted yet for this study

Summary

This clinical trial consists of two parts：1. a randomized, double-blind, single-center, placebo-controlled, dose-escalation PK study; 2. food effects and drug metabolism transformation study.

The main purpose of this trial is to evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics and Food effects of VC005 Tablets in healthy subjects.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

VC005 Tablets

VC005 Tablets 1、5、10、25、50、100mg single dose

DRUG

VC005 Tablets Placebo

VC005 Tablets Placebo 1、5、10、25、50、100mg single dose

DRUG

VC005 Tablets food effects group

VC005 Tablets qd per period, for two periods

Sponsors & Collaborators

  • Jiangsu vcare pharmaceutical technology co., LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2022-08-26
Completion
2022-08-30

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 NCT05138770 on ClinicalTrials.gov