A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Dose Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis on a Stable Dose of Methotrexate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 40
- 主要终点
- PK/PD relationship between systemic CDP6038 exposure and CRP suppression.
研究概览
简要总结
The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of CDP6038 will also be evaluated.
详细描述
The secondary objectives of the study include determination of the absolute bioavailability of CDP6038 given via sc administration compared with iv infusion; assessment of the immunogenicity potential of single dose CDP6038 and assessment, on an exploratory basis, of other relevant systemic biomarkers and changes in clinical response.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA > 6 months duration on stable Methotrexate
- •≤9 swollen and ≤9 tender joints (28 joint count)
- •Minimum Screening CRP of 0.5mg/L
排除标准
- •Participation in previous studies with defined agents and durations
- •Previous treatment with defined agents and durations
- •Presence of, or history of defined medical conditions including those particularly associated with deficiency in immune response
- •Pregnancy
- •Positive tests/signs of possible latent/active tuberculosis
- •Positive HIV
- •Drug addiction or alcohol abuse
研究组 & 干预措施
1 mg/kg CDP6038 SC and Placebo SC
Cohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc.
干预措施: Placebo SC (Other)
0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV
Cohort 1, Group 1 will compare 0.1mg/kg, 1mg/kg CDP6038 and placebo IV.
干预措施: CDP6038 (Biological)
0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV
Cohort 1, Group 1 will compare 0.1mg/kg, 1mg/kg CDP6038 and placebo IV.
干预措施: Placebo IV (Other)
0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV
Cohort 1, Group 1 will compare 0.1mg/kg, 1mg/kg CDP6038 and placebo IV.
干预措施: Methotrexate (Drug)
1 mg/kg CDP6038 SC and Placebo SC
Cohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc.
干预措施: CDP6038 (Biological)
1 mg/kg CDP6038 SC and Placebo SC
Cohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc.
干预措施: Methotrexate (Drug)
Optimized CDP6038 SC
Cohort 2, Group 3 will compare optimized sc doses of CDP6038 based on outcome of Cohort 1 with placebo.
干预措施: CDP 6038 SC (Drug)
Optimized CDP6038 SC
Cohort 2, Group 3 will compare optimized sc doses of CDP6038 based on outcome of Cohort 1 with placebo.
干预措施: Methotrexate (Drug)
结局指标
主要结局
PK/PD relationship between systemic CDP6038 exposure and CRP suppression.
时间窗: For 12 weeks following single dose
Evaluate the safety and tolerability of single doses of CDP6038 For 12 weeks following single dose
时间窗: For 12 weeks following single dose
次要结局
- Absolute bioavailability of CDP6038 given by sc injection in comparison with iv infusion(For 12 weeks following single dose)
- Assess the immunogenicity of single dose CDP6038(Multiple sampling from 0 to 12 weeks following single dose)
- Assess, on an exploratory basis, changes in clinical response and other systemic biomarkers associated with RA(For 12 weeks following single dose)