Rheumatoid ArthritisPhase 1NCT05874622
A Phase I Clinical Study of VC005 Tablets in Subjects With Rheumatoid Arthritis.
A Phase 1 study testing VC005 tablets in people with Rheumatoid Arthritis, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial summary
This is a randomized, double-blind, dose-escalating, placebo-controlled phase Ib clinical study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2023to 25 Oct 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject or his/her guardian understands and voluntarily signs the informed consent form (ICF);
- The age at the time of signing the ICF is between 18 and 70 years (including borderline values), regardless of gender;
- A body mass index [BMI = weight (kg)/height 2 (m2)] of 18 ~30 kg/m2 at the time of screening;
- Rheumatoid arthritis diagnosed according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 rheumatoid arthritis (RA) classification criteria and at least 3 months of disease duration at the time of the screening visit;
- A diagnosis of moderately or severely active RA;
- Have not used any disease-modifying antirheumatic drugs (DMARDs) prior to the first dose of the trial, or have been on a stable dose of methotrexate (MTX) for ≥4 weeks prior to the first dose, or have used methotrexate, salbutamol, or a dose of a drug such as methotrexate. (SASP), chloroquine/hydroxychloroquine, gold, penicillamine, etc., but had stopped using them for ≥3 weeks before the first dose. have stopped using the drug for ≥ 3 months;
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- Subjects who have been stable on NSAIDs prior to the first dose must have had a fixed drug class and a stable dose for ≥4 weeks and continue at a stable dose for the duration of the clinical trial;
- Subjects who have been stable on oral glucocorticoids prior to the first dose must have been stable for ≥4 weeks at a dose of ≤10 mg/day (prednisone or equivalent dose of other glucocorticoids) and continue at a stable dose for the duration of the clinical trial;
- The subject is able to communicate well with the investigator and is willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- The subjects who are allergic to the study drug or any of the components of the study drug, or are allergic (multiple drug and food allergies);
- The subjects have used any of the following medications or treatments:
- Tyrosine kinase (JAK) inhibitor class drugs, within 1 month prior to randomization/biologic disease-modifying antirheumatic drugs (bDMARDs) within 5 half-lives prior to randomization or within 3 months,etc；
- The subjects have a history or evidence of any of the following diseases:
- Presence of any systemic inflammatory disease other than RA (except secondary dry syndrome)/lymphoproliferative disease, etc;
- The presence of any abnormal laboratory test at screening that meets the following criteria (not allowed to receive within 2 weeks prior to screening) Any medical support therapy such as leukocyte boosting, anemia improvement, liver protection and enzyme reduction, blood transfusion, etc;
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- Positive hepatitis B surface antigen (HBsAg) or negative hepatitis B surface antigen, negative hepatitis B surface antibody, positive hepatitis B core antibody (HBcAb) with hepatitis B virus honeybee venom(HBV)-DNA test results above the lower limit of detection; positive hepatitis C antibody (HCVAb) with hepatitis C virus ribonucleic acid (HCV-RNA) test results above the lower limit of detection; positive syphilis spirochete antibody (TPAb) ，etc;
- Screening period ECG corrected QT interval(QTC): > 470 ms for men and > 480 ms for women, or abnormalities of clinical significance that, in the judgment of the investigator, preclude enrollment;
- Those with a history of substance abuse or drug use within the past five years;
- Those who have a positive urine drug screen or alcohol screen;
- Female patients who are planning to become pregnant or who are pregnant or breastfeeding, or who are unable to use effective contraception throughout the trial and for 6 months after the trial ends;
- Who, for any reason, are deemed by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130061
About this study
Official title: A Randomized, Double-blind, Dose-escalating, Placebo-controlled Phase Ib Clinical Study of VC005 Tablets in Subjects With Rheumatoid Arthritis.
This is a randomized, double-blind, dose-escalating, placebo-controlled phase Ib clinical study.
- Conditions
- Rheumatoid Arthritis
- Being tested
- VC005 tablets, VC005 Tablets Placebo
- Medical subject headings
- Arthritis, Rheumatoid
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 4 weeks
VC005 Tablets PlaceboDrug
VC005 placebo groups repeat administration for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| VC005 Tablets Low Dose groups | Experimental | Not described Receives: Drug: VC005 tablets |
| VC005 Tablets Medium Dose groups | Experimental | Not described Receives: Drug: VC005 tablets |
| VC005 Tablets High Dose groups | Experimental | Not described Receives: Drug: VC005 tablets |
| VC005 Tablets Placebo Low Dose groups | Experimental | Not described Receives: Drug: VC005 Tablets Placebo |
| VC005 Tablets Placebo Medium Dose groups | Experimental | Not described Receives: Drug: VC005 Tablets Placebo |
| VC005 Tablets Placebo High Dose groups | Experimental | Not described Receives: Drug: VC005 Tablets Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak time in plasma(Tmax)
Measured: Day1、Day8、Day15、Day22、Day28
Peak Plasma Concentration (Cmax）
Measured: Day1、Day8、Day15、Day22、Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start12 Jun 2023
- Primary completion18 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, Principal investigator, The First Hospital of Jilin UniversityNanya Wang, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874622
- Sponsor's protocol ID
- VC005-103
- Status last verified
- Nov 2023
- First submitted
- 5 May 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Dose-escalating, Placebo-controlled Phase Ib Clinical Study of VC005 Tablets in Subjects With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT05874622
- Acronym / sponsor ID
- VC005-103
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 25 May 2023 (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 is a randomized, double-blind, dose-escalating, placebo-controlled phase Ib clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| VC005 Tablets Low Dose groups | Experimental | Drug: VC005 tablets |
| VC005 Tablets Medium Dose groups | Experimental | Drug: VC005 tablets |
| VC005 Tablets High Dose groups | Experimental | Drug: VC005 tablets |
| VC005 Tablets Placebo Low Dose groups | Experimental | Drug: VC005 Tablets Placebo |
| VC005 Tablets Placebo Medium Dose groups | Experimental | Drug: VC005 Tablets Placebo |
| VC005 Tablets Placebo High Dose groups | Experimental | Drug: VC005 Tablets Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject or his/her guardian understands and voluntarily signs the informed consent form (ICF);
- The age at the time of signing the ICF is between 18 and 70 years (including borderline values), regardless of gender;
- A body mass index [BMI = weight (kg)/height 2 (m2)] of 18 ~30 kg/m2 at the time of screening;
- Rheumatoid arthritis diagnosed according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 rheumatoid arthritis (RA) classification criteria and at least 3 months of disease duration at the time of the screening visit;
- A diagnosis of moderately or severely active RA;
Key exclusion criteria (12 listed)
- The subjects who are allergic to the study drug or any of the components of the study drug, or are allergic (multiple drug and food allergies);
- The subjects have used any of the following medications or treatments:
- Tyrosine kinase (JAK) inhibitor class drugs, within 1 month prior to randomization/biologic disease-modifying antirheumatic drugs (bDMARDs) within 5 half-lives prior to randomization or within 3 months,etc；
- The subjects have a history or evidence of any of the following diseases:
- Presence of any systemic inflammatory disease other than RA (except secondary dry syndrome)/lymphoproliferative disease, etc;
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 4 weeks | Drug | VC005 Tablets High Dose groups, VC005 Tablets Low Dose groups, VC005 Tablets Medium Dose groups |
| VC005 Tablets PlaceboVC005 placebo groups repeat administration for 4 weeks | Drug | VC005 Tablets Placebo High Dose groups, VC005 Tablets Placebo Low Dose groups, VC005 Tablets Placebo Medium Dose groups |
Primary outcome
Peak time in plasma(Tmax)
Time frame: Day1、Day8、Day15、Day22、Day28
Peak Plasma Concentration (Cmax）
Time frame: Day1、Day8、Day15、Day22、Day28
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 3 Nov 2023.
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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.
Yanhua Ding principal investigator
The First Hospital of Jilin University
Nanya Wang principal investigator
The First Hospital of Jilin University
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 Rheumatoid Arthritis, 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 9 inclusion and 12 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 3 Nov 2023. 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. 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 time in plasma(Tmax) (time frame: Day1、Day8、Day15、Day22、Day28). The study lists 2 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 3 Nov 2023.