NCT04457856Unknown1 期
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
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 63
- 试验地点
- 5
- 主要终点
- Number of subject with adverse events(AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Multiple Ascending Dose: DAS28 score≤5.1 and >3.
- •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.
排除标准
- •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.
结局指标
主要结局
Number of subject with adverse events(AEs)
时间窗: 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
次要结局
- 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)
- Maximum observed plasma concentration (Cmax) of TJ003234(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(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(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(Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part)
研究者
研究点 (5)
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