Clinical trial NCT04457856: A Study of TJ003234 in Rheumatoid Arthritis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
biologics
Lead sponsor: I-Mab Biopharma US Limited
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-blind, Placebo-controlled
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of subject with adverse events(AEs)
timeFrame: 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)
Secondary outcomes:
measure: AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234
timeFrame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
measure: Maximum observed plasma concentration (Cmax) of TJ003234
timeFrame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
measure: The proportion of subjects who produce anti-drug antibodies
timeFrame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
measure: The proportion of subjects who produce neutralizing antibodies
timeFrame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
measure: The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies
timeFrame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The first affiliated hospital of bengbu medical college
state: Anhui
city: Beijing
country: China
facility: Peking university people's Hospital
state: Beijing
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital southeast university
state: Jiangsu
city: Shanghai
country: China
facility: FuDan University shanghai huashan Hospital
state: Shanghai
Study officials:
References: