A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- To assess the safety and tolerability of a single dose of subcutaneously administered REGN88 in subjects with rheumatoid arthritis who are receiving concomitant treatment with methotrexate
研究概览
简要总结
This study will test the safety and tolerability (how the body reacts to the drug) of REGN88 and placebo (an inactive substance that contains no medicine) in patients with Rheumatoid Arthritis.
详细描述
This is a multi-center, randomized, double blind, placebo-controlled, single dose escalation study of the safety and tolerability of subcutaneously administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate.
Three (3) sequential dose cohorts of 5 subjects (4:1 active: placebo) will be dosed SC with REGN88 or placebo. Subjects who complete the study will participate in 14 study visits over 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age
- •Subjects must weigh > 50 kg and < 100 kg
- •Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with disease duration of no less than 6 months and ACR class I-III
- •For women of childbearing potential, a negative serum pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at Day -1
- •For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study.
排除标准
- •A history of Listeriosis or active tuberculosis (TB)
- •Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit
- •History of prior articular or prosthetic joint infection
- •History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
- •Significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study
- •Received administration of any live (attenuated) vaccine within 3 months prior to the Screening Visit
结局指标
主要结局
To assess the safety and tolerability of a single dose of subcutaneously administered REGN88 in subjects with rheumatoid arthritis who are receiving concomitant treatment with methotrexate
时间窗: 113 Days
次要结局
- To assess the PK profile of a single subcutaneous (SC) dose of REGN88, and the immunogenicity of a single SC dose of REGN88(113 days)