NCT03168984已完成1 期
A Single-Centre, Investigator/Subject Blind, Placebo-Controlled, Single and Multiple Oral Dose Investigation of Safety, Tolerability, and Pharmacokinetics of UCB0942 in Healthy Japanese and Caucasian Subjects
UCB Biopharma S.P.R.L.1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年5月5日最近更新:
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
- 48
- 试验地点
- 1
- 主要终点
- Cmax: maximum observed plasma concentration of UCB0942 and metabolites
研究概览
简要总结
The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of UCB0942 in Japanese and Caucasian 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is male or female and between 20 and 55 years of age (inclusive)
- •Subject is in good physical and mental health
- •Female subjects will use an efficient form of contraception for the duration of the study (unless menopausal)
- •Male subject agrees that, during the study period, when having sexual intercourse with a woman of childbearing potential, he will use an efficient barrier contraceptive AND that the respective partner will use an additional efficient contraceptive method
- •For Japanese subjects: Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan)
- •For Caucasians: Subject is of Caucasian descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has 4 Caucasian grandparents).
排除标准
- •At screening:
- •Previous study participation with another investigational medicinal product (IMP) within 3 months
- •History of alcohol/drug abuse
- •History of psychiatric condition and suicide attempt
- •Any medical condition unfit for study (including history of cancer)
- •History of hypersensitivity for IMP components
- •Taking concomitant medications
- •Positive for human immunodeficiency virus (HIV)/ hepatitis B virus (HBV)/ hepatitis C virus (HCV)
- •Abnormal liver function tests (LFTs), abnormal safety bloods/ vitals/ physical examination and electrocardiogram (ECG) findings
- •Positive for pregnancy test
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
UCB0942
Experimental
Cohort 1 (Japanese subjects): Single dose of UCB0942 (dosage regimen 1) Cohort 2 (Japanese subjects): Single dose of UCB0942 (dosage regimen 2) Cohort 3 (Japanese subjects): Single dose of UCB0942 (dosage regimen 3) followed, after maximum 21 days, by multiple doses of UCB0942 (dosage regimen 2) Cohort 4 (Caucasian subjects): Single dose of UCB0942 (dosage regimen 3) followed, after maximum 21 days, by multiple doses of UCB0942 (dosage regimen 2)
干预措施: UCB0942 (Drug)
Placebo
Placebo Comparator
Cohort 1 and Cohort 2: Single dose of Placebo Cohort 3 and Cohort 4: Single dose of Placebo followed, after maximum 21 days, by multiple doses of Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Cmax: maximum observed plasma concentration of UCB0942 and metabolites
时间窗: Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose.
AUC(0-t): area under the plasma concentration-time curve from time zero to the time of last detectable concentration for UCB0942 and metabolites
时间窗: Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose.
次要结局
- tmax: time of maximum concentration of UCB0942 and metabolites during the Single-dose period(Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose.)
- Change from baseline in laboratory variables, vital sign variables, 12-lead ECG variables and physical examination(From Baseline until safety follow up visit (up to Week 18))
- t1/2: apparent terminal elimination half-life of UCB0942 and metabolites during the Single-dose period(Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose.)
- AUC: area under the plasma concentration-time curve from time zero to infinity for UCB0942 and metabolites during the Single-dose period(Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose.)
- t1/2: apparent terminal elimination half-life of UCB0942 and metabolites during the Multiple-dose period(Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose.)
- AUCtau: area under the curve over a dosing interval (12hrs) for UCB0942 and metabolites during the Single-dose period(Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose.)
- RAUC: Accumulation ratio of AUCtau for UCB0942 and metabolites during the Multiple-dose period(Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose.)
- tmax: time of maximum concentration of UCB0942 and metabolites during the Multiple-dose period(Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose.)
- RCmax: Accumulation ratio of Cmax for UCB0942 and metabolites during the Multiple-dose period(Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose.)
- AUCtau: area under the curve over a dosing interval (12hrs) for UCB0942 and metabolites during the Multiple-dose period(Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose.)
- Adverse events (AEs) reported spontaneously by the subject or observed by the investigator(From Screening until safety follow up visit (up to Week 18))
研究者
研究点 (1)
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