NCT02873767已完成1 期
A Subject-Blind, Investigator-Blind, Randomized, Placebo-Controlled, First-In-Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of UCB4019 in Healthy Subjects
UCB Biopharma S.P.R.L.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events during the study
研究概览
简要总结
This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good physical and mental health
- •At least 18 and less than 65 years of age
- •Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their last dose of study drug
排除标准
- •Total Immunoglobulin G <7 g/L or >16 g/L at the Screening Visit
- •Absolute neutrophil count <1.5x10^9/L and/or lymphocyte count <1.0x10^9/L
- •Known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive
- •Positive test to Human Immunodeficiency Virus (HIV) 1/2 antibodies
- •Past medical history or family history of primary immunodeficiency
- •Evidence of latent/active Tuberculosis (TB)
- •Active infection or a serious infection within 6 weeks before the first dose of IMP
- •Renal impairment
- •Hepatic impairment
- •Vaccination within 6 weeks before the Screening Visit or intent to have a vaccination before Day 43 of the Safety Follow-up Period
- •Subject is splenectomized
- •received any IMP or experimental procedure within 90 days before the first dose of IMP
- •received UCB7665 in a clinical study
研究组 & 干预措施
Placebo
Placebo Comparator
Single dose placebo comparator for each active arm
干预措施: PL1 (Other)
UCB4019 Dose 1
Experimental
Dose 1 calculated based on body weight
干预措施: PR1 (Drug)
UCB4019 Dose 2
Experimental
Dose 2 calculated based on body weight
干预措施: PR1 (Drug)
UCB4019 Dose 3
Experimental
Dose 3 calculated based on body weight
干预措施: PR1 (Drug)
UCB4019 Dose 4
Experimental
Dose 4 calculated based on body weight
干预措施: PR1 (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events during the study
时间窗: Day 1 up to Day 57
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
次要结局
- Time to reach Cmax (Tmax)(Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19)
- Change from Baseline in total Immunoglobulin G (IgG) concentration at day 13(Predose (Day 1), Day 13)
- Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7(Predose (Day 1), Day 7)
- Maximum plasma concentration (Cmax)(Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19)
- Area under the curve from 0 to time t, the time of last quantifiable concentration [(AUC0-t)](Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19)
- Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10(Predose (Day 1), Day 10)
研究者
研究点 (1)
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