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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Drug: VC005 Tablets; Drug: VC005 Tablets Placebo; Drug: VC005 Tablets food effects group

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male or female subjects aged 18 to 45 years old，inclusive
2. 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
3. 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
4. Volunteer to participate in the trial and sign an informed consent form
5. 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
6. Physical examination and vital signs are normal or abnormal with no clinical significance

Exclusion Criteria:

1. Suspected to be allergic to the study drug or any component in the study drug, or allergic constitution
2. abnormal electrocardiogram with clinical significance
3. Those who have evidence of atypical hyperplasia or a history of malignant tumor
4. Suffer from eye diseases, including history of eye surgery or laser surgery (except laser surgery for myopia)
5. Those who have a history of herpes simplex or herpes zoster 3 months before administration
6. 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
7. 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
8. Those who have participated in clinical trials of any drug or medical device (including the placebo group) within 3 months before screening
9. Those who have been vaccinated within 2 weeks before administration, or plan to be vaccinated during the study period
10. 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
11. Those who have undergone any surgeries within 6 months before screening
12. Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines within 14 days before screening
13. Those who use any drug that inhibits or induces liver enzyme activity within 28 days before administration or during the study period
14. Those who were in blood donation within 3 months before screening and donated blood volume ≥400 mL, or received blood transfusion
15. Those who with dyslipidemia of clinical significance and coronary heart disease
16. Pregnant and lactating females, or females who have a positive pregnancy test
17. Those who have difficulty in blood collection or cannot tolerate venipuncture, and those who have a history of fainting needles and bleeding
18. Those who smoke ≥ 5 cigarettes per day within 3 months before screening and cannot stop using any tobacco products from the end of screening to before enrollment and during the test
19. Those who drink more than 14 units of alcohol per week within 3 months prior to administration (1 unit of alcohol ≈ 360 mL beer or 45 mL 40% alcohol spirits or 150 mL wine), or those who cannot abstain from alcohol during the study
20. Those who have taken any food or drink that affects absorption, distribution, metabolism, and excretion of the drug within 24 hours before administration, such as food or drink containing caffeine (such as chocolate) and xanthine
21. Those who have consumed pithya , mango, grapefruit, lime, star fruit, or food or beverage prepared therefrom 2 weeks before the first administration
22. Clinically significant clinical laboratory abnormalities or other clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immunological, psychiatric or cardiovascular diseases)
23. Those who are positive in urine drug and alcohol test
24. Hepatitis B surface antigen, hepatitis C antibody / hepatitis C core antigen, HIV antigen / antibody, syphilis antibody positive
25. Subjects with other factors not suitable for the trial considered by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VC005 Tablets Dose escalation groups: 1、5、10、25、50、100mg; VC005 Tablets 1、5、10、25、50、100mg, qd	Drug: VC005 Tablets; VC005 Tablets 1、5、10、25、50、100mg single dose
Placebo Comparator: VC005 Tablets Placebo Dose escalation groups: 1、5、10、25、50、100mg; VC005 Tablets Placebo 1、5、10、25、50、100mg, qd	Drug: VC005 Tablets Placebo; VC005 Tablets Placebo 1、5、10、25、50、100mg single dose
Experimental: VC005 Tablets food effects group; VC005 Tablets, qd	Drug: VC005 Tablets food effects group; VC005 Tablets qd per period, for two periods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Actual): August 26, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: healthy subjects
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: VC005-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No