Multiple-dose Escalation Clinical Study of VC005 Tablets in Healthy Subjects
Primary Purpose
Inflammatory Bowel Diseases
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
VC005 tablets
VC005 Placebo tablets
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring healthy subjects
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Pregnant and lactating females, or females who have a positive pregnancy test
- Those who have difficulty in blood collection or cannot tolerate venipuncture, and those who have a history of fainting needles and bleeding
- 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
- 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
- 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
- Those who have consumed pithya , mango, grapefruit, lime, star fruit, or food or beverage prepared therefrom 2 weeks before the first administration
- 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)
- Those who are positive in urine drug and alcohol test
- Hepatitis B surface antigen, hepatitis C antibody / hepatitis C core antigen, HIV antigen / antibody, syphilis antibody positive
- Subjects with other factors not suitable for the trial considered by the investigator
Sites / Locations
- The First Hospital of Jilin University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
VC005 Tablets Dose escalation groups
VC005 Tablets Placebo groups
Arm Description
VC005 Tablets groups Repeat doses
VC005 Tablets Placebo groups Repeat doses.
Outcomes
Primary Outcome Measures
Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)
Peak time in plasma(Tmax)
Area under the plasma concentration versus time curve during the dosing interval(AUC0-τ)
minimum plasma concentration at steady state(Cmin,ss)
Secondary Outcome Measures
Full Information
NCT ID
NCT05354752
First Posted
April 20, 2022
Last Updated
November 16, 2022
Sponsor
Jiangsu vcare pharmaceutical technology co., LTD
1. Study Identification
Unique Protocol Identification Number
NCT05354752
Brief Title
Multiple-dose Escalation Clinical Study of VC005 Tablets in Healthy Subjects
Official Title
Randomized, Double-blind, Multiple-dose Escalation, Placebo-controlled Phase I Clinical Study to Evaluate the Tolerance, Pharmacokinetics and Pharmacodynamics of VC005 Tablets in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 18, 2022 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu vcare pharmaceutical technology co., LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial is a randomized, double-blind, single-center, placebo-controlled and multiple-dose escalation Pharmacokinetics study
Detailed Description
The main purpose of this trial is to evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of VC005 Tablets in healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
healthy subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VC005 Tablets Dose escalation groups
Arm Type
Experimental
Arm Description
VC005 Tablets groups Repeat doses
Arm Title
VC005 Tablets Placebo groups
Arm Type
Placebo Comparator
Arm Description
VC005 Tablets Placebo groups Repeat doses.
Intervention Type
Drug
Intervention Name(s)
VC005 tablets
Intervention Description
VC005 groups repeat administration for 7 days
Intervention Type
Drug
Intervention Name(s)
VC005 Placebo tablets
Intervention Description
VC005 placebo groups repeat administration for 7 days
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Time Frame
Day 2
Title
Area under the plasma concentration versus time curve (AUC)
Time Frame
Day 2
Title
Peak time in plasma(Tmax)
Time Frame
Day 2
Title
Area under the plasma concentration versus time curve during the dosing interval(AUC0-τ)
Time Frame
Day 9
Title
minimum plasma concentration at steady state(Cmin,ss)
Time Frame
Day 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Pregnant and lactating females, or females who have a positive pregnancy test
Those who have difficulty in blood collection or cannot tolerate venipuncture, and those who have a history of fainting needles and bleeding
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
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
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
Those who have consumed pithya , mango, grapefruit, lime, star fruit, or food or beverage prepared therefrom 2 weeks before the first administration
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)
Those who are positive in urine drug and alcohol test
Hepatitis B surface antigen, hepatitis C antibody / hepatitis C core antigen, HIV antigen / antibody, syphilis antibody positive
Subjects with other factors not suitable for the trial considered by the investigator
Facility Information:
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
12. IPD Sharing Statement
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Multiple-dose Escalation Clinical Study of VC005 Tablets in Healthy Subjects
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