Pharmacokinetics and Pharmacodynamics Clinical Study of VC005 Tablets in Healthy Subjects

NCT05138770 | Completed Phase 1

• 1 other identifier: VC005-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

healthy subjects

Outcome Measures

Primary Outcomes (5)

• Peak Plasma Concentration (Cmax）

  Day 4

• Area under the plasma concentration versus time curve (AUC)

  Day 4

• Peak time in plasma(Tmax)

  Day 4

• Accumulative urine excretion rate

  Day 4

• Accumulative fecal excretion rate

  Day 4

Study Arms (3)

VC005 Tablets Dose escalation groups: 1、5、10、25、50、100mg

EXPERIMENTAL

VC005 Tablets 1、5、10、25、50、100mg, qd

Drug: VC005 Tablets

VC005 Tablets Placebo Dose escalation groups: 1、5、10、25、50、100mg

PLACEBO COMPARATOR

VC005 Tablets Placebo 1、5、10、25、50、100mg, qd

Drug: VC005 Tablets Placebo

VC005 Tablets food effects group

EXPERIMENTAL

VC005 Tablets, qd

Drug: VC005 Tablets food effects group

Interventions

VC005 Tablets DRUG

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

VC005 Tablets Dose escalation groups: 1、5、10、25、50、100mg

VC005 Tablets Placebo DRUG

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

VC005 Tablets Placebo Dose escalation groups: 1、5、10、25、50、100mg

VC005 Tablets food effects group DRUG

VC005 Tablets qd per period, for two periods

VC005 Tablets food effects group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects aged 18 to 45 years old，inclusive
• Male subjects weighing at least 50 kg and female subjects weighing at least 45 kg. Body mass index (BMI) between 18 and 28 kg/m2, inclusive
• During the trial and within 3 months after the completion of the trial (the time should exceed the time required for sperm production), there is no fertility plan, and is willing to use effective contraceptive measures (non hormonal contraceptive measures) and there is no sperm donation and egg donation plan
• Volunteer to participate in the trial and sign an informed consent form
• Subjects who are able to communicate well with the investigator are willing and able to comply with all planned visits, treatment plans, laboratory examinations and other research procedures
• Physical examination and vital signs are normal or abnormal with no clinical significance

You may not qualify if:

• Suspected to be allergic to the study drug or any component in the study drug, or allergic constitution
• abnormal electrocardiogram with clinical significance
• Those who have evidence of atypical hyperplasia or a history of malignant tumor
• Suffer from eye diseases, including history of eye surgery or laser surgery (except laser surgery for myopia)
• Those who have a history of herpes simplex or herpes zoster 3 months before administration
• Have any history or evidence of active tuberculosis (TB) or latent TB infection (TB enzyme-linked immunospot test (T-SPOT. TB) positive), or have a history of previous skin TB test or QuantiFERON TB gold in tube test (GIT analysis) positive
• Known active bacteria, viruses, fungi, parasitic infections or other infections or any infections that require antibiotic treatment or hospitalization (4 weeks before screening), or any acute infections within 2 weeks of baseline
• Those who have participated in clinical trials of any drug or medical device (including the placebo group) within 3 months before screening
• Those who have been vaccinated within 2 weeks before administration, or plan to be vaccinated during the study period
• Those who are usually anorexia, dieting, or have started a significantly abnormal diet (such as dieting) within 4 weeks before screening; those who cannot follow a uniform diet or have difficulty swallowing
• Those who have undergone any surgeries within 6 months before screening
• Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines within 14 days before screening
• Those who use any drug that inhibits or induces liver enzyme activity within 28 days before administration or during the study period
• Those who were in blood donation within 3 months before screening and donated blood volume ≥400 mL, or received blood transfusion
• Those who with dyslipidemia of clinical significance and coronary heart disease

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: December 1, 2021
• Study Start: November 18, 2021
• Primary Completion: August 26, 2022
• Study Completion: August 30, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

CN (1)