Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single Rising, Open-label Doses of AbGn-168 Administered by Intravenous Infusion (1 Mcg/kg, 5 Mcg/kg, 25 Mcg/kg, 125 Mcg/kg, 625 Mcg/kg, 3 mg/kg, or 10 mg/kg) or Subcutaneous Injection (625 Mcg/kg) to Patients With Chronic Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests, and adverse events
研究概览
简要总结
The general aim of the trial is to determine the safety, tolerability and pharmacologic profile of single escalating doses of AbGn-168 administered subcutaneously or intravenously to patients with chronic plaque psoriasis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
arm 5
AbGn168 cohort 5
干预措施: AbGn168 intravenous infusion (Drug)
arm 1
AbGn168 cohort 1
干预措施: AbGn168 intravenous infusion (Drug)
arm 2
AbGn168 cohort 2
干预措施: AbGn168 intravenous infusion (Drug)
arm 3
AbGn168 cohort 3
干预措施: AbGn168 intravenous infusion (Drug)
arm 4
AbGn168 cohort 4
干预措施: AbGn168 intravenous infusion (Drug)
arm 6
AbGn168 cohort 6
干预措施: AbGn168 intravenous infusion (Drug)
arm 7
AbGn168 cohort 7
干预措施: AbGn168 intravenous infusion (Drug)
arm 8
AbGn168 cohort 8
干预措施: AbGn168 subcutaneous injection (Drug)
结局指标
主要结局
Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests, and adverse events
时间窗: Baseline, on treatment,and at end of study
次要结局
- Pharmacokinetic and pharmacodynamic endpoints including Cmax, tmax, AUC, t1/2, CL and Vss, target lesion assessment and skin biopsy(Baseline and on treatment)