A Phase 1, Single- and Multiple-Dose Study to Assess the Safety and Pharmacokinetics of Ixekizumab (LY2439821) (Anti-IL-17 Humanized Antibody) in Chinese Patients With Psoriasis Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)
研究概览
简要总结
The purpose of the study is to research how much ixekizumab enters the bloodstream and how long the body takes to get rid of the drug and the safety of ixekizumab and any side effects that might be associated with it. The study has two parts: A single-dose part and multiple-dose part. The single dose part of this study will last up to 24 weeks, including the screening period. The multiple dose part of this study will last up to 32 weeks including the screening period.
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
- None
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
- •Males or females aged ≥18 years.
- •Diagnosis of chronic plaque psoriasis for ≥6 months before baseline.
- •Candidates for phototherapy and/or systemic therapy.
- •≥10% body surface area (BSA) involvement at screening and baseline.
- •static Physician's Global Assessment (sPGA) score ≥3, and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline.
排除标准
- •Clinically significant flare of psoriasis during the 12 weeks before baseline.
- •Systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to baseline .
- •Current or recent use of any biologic agent within the required washout periods.
- •Clinical evidence or suspicion of active tuberculosis or previously had evidence of active tuberculosis and did not receive appropriate and documented treatment.
研究组 & 干预措施
Ixekizumab single dose
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
干预措施: Ixekizumab (Drug)
Ixekizumab Multiple Regimen 1 (80mg Q2W)
Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
干预措施: Ixekizumab (Drug)
Ixekizumab Multiple Regimen 2 (80mg Q4W)
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
干预措施: Ixekizumab (Drug)
结局指标
主要结局
Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)
时间窗: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)
时间窗: day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197
Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)
时间窗: Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.
Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)
时间窗: day 57 (Pre-dose), 59, 61, 64, 67, 71
Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose).
Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose)
时间窗: day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85
Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).
次要结局
未报告次要终点