Inflammatory Bowel DiseasesPhase 1NCT05354752
Multiple-dose Escalation Clinical Study of VC005 Tablets in Healthy Subjects
A Phase 1 study testing VC005 tablets in people with Inflammatory Bowel Diseases, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial summary
This clinical trial is a randomized, double-blind, single-center, placebo-controlled and multiple-dose escalation Pharmacokinetics study Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- VC005 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2022to 15 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This clinical trial is a randomized, double-blind, single-center, placebo-controlled and multiple-dose escalation Pharmacokinetics study
Read the detailed description
The main purpose of this trial is to evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of VC005 Tablets in healthy subjects.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- VC005 tablets, VC005 Placebo tablets
- Keywords
- healthy subjects
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC005 tabletsDrug
VC005 groups repeat administration for 7 days
VC005 Placebo tabletsDrug
VC005 placebo groups repeat administration for 7 days
| Study group | Role | What they receive |
|---|---|---|
| VC005 Tablets Dose escalation groups | Experimental | VC005 Tablets groups Repeat doses Receives: Drug: VC005 tablets |
| VC005 Tablets Placebo groups | Placebo comparator | VC005 Tablets Placebo groups Repeat doses. Receives: Drug: VC005 Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax）
Measured: Day 2
Area under the plasma concentration versus time curve (AUC)
Measured: Day 2
Peak time in plasma(Tmax)
Measured: Day 2
Area under the plasma concentration versus time curve during the dosing interval(AUC0-τ)
Measured: Day 9
minimum plasma concentration at steady state(Cmin,ss)
Measured: Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start18 Jun 2022
- Primary completion2 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Jiangsu vcare pharmaceutical technology co., LTDThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354752
- Sponsor's protocol ID
- VC005-102
- Status last verified
- Jun 2022
- First submitted
- 20 Apr 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05354752
- Acronym / sponsor ID
- VC005-102
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VC005 Tablets Dose escalation groups | Experimental | Drug: VC005 tabletsVC005 Tablets groups Repeat doses |
| VC005 Tablets Placebo groups | Placebo comparator | Drug: VC005 Placebo tabletsVC005 Tablets Placebo groups Repeat doses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VC005 tabletsVC005 groups repeat administration for 7 days | Drug | VC005 Tablets Dose escalation groups |
| VC005 Placebo tabletsVC005 placebo groups repeat administration for 7 days | Drug | VC005 Tablets Placebo groups |
Primary outcome
Peak Plasma Concentration (Cmax）
Time frame: Day 2
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 2
Peak time in plasma(Tmax)
Time frame: Day 2
Area under the plasma concentration versus time curve during the dosing interval(AUC0-τ)
Time frame: Day 9
minimum plasma concentration at steady state(Cmin,ss)
Time frame: Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VC005 tablets in people with Inflammatory Bowel Diseases, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax） (time frame: Day 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.