search
Back to results

A Phase I Clinical Study of VC005 Tablets in Subjects With Rheumatoid Arthritis.

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
VC005 tablets
VC005 Tablets Placebo
Sponsored by
Jiangsu vcare pharmaceutical technology co., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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; 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. Exclusion Criteria: 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; 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.

Sites / Locations

  • The First Bethune Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

VC005 Tablets Low Dose groups

VC005 Tablets Medium Dose groups

VC005 Tablets High Dose groups

VC005 Tablets Placebo Low Dose groups

VC005 Tablets Placebo Medium Dose groups

VC005 Tablets Placebo High Dose groups

Arm Description

Outcomes

Primary Outcome Measures

Peak time in plasma(Tmax)
Peak Plasma Concentration (Cmax)

Secondary Outcome Measures

Full Information

First Posted
May 5, 2023
Last Updated
August 10, 2023
Sponsor
Jiangsu vcare pharmaceutical technology co., LTD
search

1. Study Identification

Unique Protocol Identification Number
NCT05874622
Brief Title
A Phase I Clinical Study of VC005 Tablets in Subjects With Rheumatoid Arthritis.
Official Title
A Randomized, Double-blind, Dose-escalating, Placebo-controlled Phase Ib Clinical Study of VC005 Tablets in Subjects With Rheumatoid Arthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

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

5. Study Description

Brief Summary
This is a randomized, double-blind, dose-escalating, placebo-controlled phase Ib clinical study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VC005 Tablets Low Dose groups
Arm Type
Experimental
Arm Title
VC005 Tablets Medium Dose groups
Arm Type
Experimental
Arm Title
VC005 Tablets High Dose groups
Arm Type
Experimental
Arm Title
VC005 Tablets Placebo Low Dose groups
Arm Type
Experimental
Arm Title
VC005 Tablets Placebo Medium Dose groups
Arm Type
Experimental
Arm Title
VC005 Tablets Placebo High Dose groups
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
VC005 tablets
Intervention Description
VC005 groups repeat administration for 4 weeks
Intervention Type
Drug
Intervention Name(s)
VC005 Tablets Placebo
Intervention Description
VC005 placebo groups repeat administration for 4 weeks
Primary Outcome Measure Information:
Title
Peak time in plasma(Tmax)
Time Frame
Day1、Day8、Day15、Day22、Day28
Title
Peak Plasma Concentration (Cmax)
Time Frame
Day1、Day8、Day15、Day22、Day28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojuan Lai
Phone
15358160458
Email
lai_xiaojuan@vcarepharmatech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanhua Ding
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nanya Wang
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanhua Ding
Phone
18186879768
Email
dingyanhua2003@126.com
First Name & Middle Initial & Last Name & Degree
Nanya Wang
Phone
15804302611
Email
wangny@jlu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

A Phase I Clinical Study of VC005 Tablets in Subjects With Rheumatoid Arthritis.

We'll reach out to this number within 24 hrs