A Study of TJ003234 in Rheumatoid Arthritis Patients
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: TJ003234 injection
- Registration Number
- NCT04457856
- Lead Sponsor
- I-Mab Biopharma US Limited
- Brief Summary
Study Purpose and Design: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 63
- Subjects must be ≥ 18 and ≤70 years old when signing the informed consent, with no limitation of gender.
- Established Rheumatoid arthritis patients, diagnosed by ACR/EULAR criteria 2010 at least 6 months prior to randomisation.
- Single Ascending Dose: DAS28 score≤3.2. Multiple Ascending Dose: DAS28 score≤5.1 and >3.2.
- Allowed one or more standard treatments, but the start date should no later than 12 weeks(84 days) before the randomisation and should take at a stable dose more than 4 weeks(28 days) before the randomisation. The combination taken of Methotrexate (MTX) and leflunomide was not allowed within 4 weeks (28 days) before randomization.
- Subjects must agree to attendance the study and signed the inform concent by themselves.
- Subjects(include subjects's wife) are no pregnancy plan during the sceering and 3 months after complete the study and agree to use contraceptives that protocol suggest.
- Employees of the hospital or any other person that paticipant in the study and their immedidte family members.
- A documented history of an autoimmune disease other than RA (other than secondary Sjögren's syndrome) .
- Previous received Any biologic DMARD therapy including tsDMARD. •A positive hepatitis B (HBsAg, anti-HBc, and/or IgM anti-HBc), hepatitis C or HIV test at screening, indicative of a current or past infection.
- A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon TB Gold or T-SPOT).
- Female patients who are pregnant during the study, or are breastfeeding. •Malignancy, or prior malignancy, with a disease free interval of <5 years after diagnosis and intervention except curative treatment for basal and squamous cell skin cancer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo TJ003234 injection Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion TJ003234 TJ003234 injection Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion
- Primary Outcome Measures
Name Time Method Number of subject with adverse events(AEs) First dose up to last follow-up visit (i.e. 90 days after dosing for single dose part, 140 days after first dose for multiple dose part) Number of subject with adverse events(AEs) to evaluate satety in patient with RA with vital signs, Electrocardiograms, physical examinations, laboratory tests and respiratory-related examinations
- Secondary Outcome Measures
Name Time Method AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234 Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234
Maximum observed plasma concentration (Cmax) of TJ003234 Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part Maximum observed plasma concentration (Cmax) of TJ003234
The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies
The proportion of subjects who produce anti-drug antibodies Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part The proportion of subjects who produce anti-drug antibodies
The proportion of subjects who produce neutralizing antibodies Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part The proportion of subjects who produce neutralizing antibodies
Trial Locations
- Locations (5)
Peking university people's Hospital
🇨🇳Beijing, Beijing, China
The first affiliated hospital of bengbu medical college
🇨🇳Bengbu, Anhui, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Zhongda Hospital southeast university
🇨🇳Nanjing, Jiangsu, China
FuDan University shanghai huashan Hospital
🇨🇳Shanghai, Shanghai, China