NCT05138770

Pharmacokinetics and Pharmacodynamics Clinical Study of VC005 Tablets in Healthy Subjects

Randomized, Double-blind, Dose-escalation, Placebo-controlled Single Administration Phase Ia Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics and Food Effects of VC005 Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Jiangsu vcare pharmaceutical technology co., LTD · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-11-18
• Primary completion: 2022-08-26
• Completion: 2022-08-30
• First posted: 2021-12-01
• Last updated: 2022-09-02

Locations

1 site across 1 country: China