NCT02144272已完成1 期
A Phase 1 Single-Dose, Dose Escalation Study to Evaluate the Safety and Tolerability of LY3114062 in Subjects With Inflammatory Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- The Number of Participants with One or More Drug-Related Adverse Events
研究概览
简要总结
The main purpose of this study is to learn more about the safety of LY3114062 and to find out how well it is tolerated in participants with an inflammatory arthritis. The study will also investigate how the body processes the drug and how the drug affects inflammatory arthritis. The study is expected to last about 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signs or symptoms of an inflammatory arthritis for a duration of at least 8 weeks at screening.
- •Presence of at least 3 out of 66 swollen joints at screening and baseline, as determined by the swollen joint count assessment forms.
排除标准
- •Synthetic disease-modifying antirheumatic drugs DMARD use as follows:
- •ANY treatment with tofacitinib within 28 days prior to baseline or planned treatment with tofacitinib during the study;
- •Treatment with other synthetic DMARDs (eg, hydroxychloroquine, methothrexate, leflunomide, sulfasalazine, and gold salts) at an unstable dose within 28 days prior to baseline or if the dose of drug is planned to be changed during the study.
- •Previous treatment with marketed biologic DMARDs as follows:
- •Etanercept, adalimumab, or anakinra <4 weeks prior to baseline;
- •Infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab <8 weeks prior to baseline;
- •Rituximab <12 months prior to baseline
- •Note: Other biologic agents for indications other than an inflammatory arthritis may be allowed after discussion with the sponsor
- •Treatment with >10 mg/day, or unstable dose, of oral prednisone or equivalent within 28 days prior to baseline.
- •Confirmed or suspected septic arthritis, crystal arthropathy, systemic lupus erythematosus, reactive arthritis, or certain other rheumatic conditions.
研究组 & 干预措施
LY3114062 (SC)
Experimental
LY3114062 given as a single subcutaneous (SC) dose, in escalating dose cohorts starting at 2 mg.
干预措施: LY3114062 SC (Drug)
LY3114062 (IV)
Experimental
LY3114062 given once intravenous (IV).
干预措施: LY3114062 IV (Drug)
Placebo
Placebo Comparator
Placebo (sodium chloride injection) given as a single SC dose.
干预措施: Placebo (Drug)
结局指标
主要结局
The Number of Participants with One or More Drug-Related Adverse Events
时间窗: Baseline to study completion (3 months)
次要结局
- Antibody Production Against LY3114062(Day 1, 8, 15, 29, 85 and early discontinuation)
- Pharmacokinetics: Area Under the Concentration-time curve (AUC) of LY3114062(Predose through Day 85, at specified timepoints)
- Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3114062(Predose through Day 85, at specified timepoints)
研究者
研究点 (1)
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