NCT02879877已完成1 期
A Subject-blind, Investigator-blind, Randomized, Placebo-controlled, First-in-human Study Evaluating the Safety/Tolerability, Pharmacokinetics, Effect on Transglutaminase 2 Expression, and Occupancy of Single Ascending Intravenous and Subcutaneous Doses of UCB7858 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 78 人开始时间: 2016年7月11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
- 78
- 试验地点
- 1
- 主要终点
- Incidence of adverse events following administration of UCB7858
研究概览
简要总结
This study is designed to evaluate the safety and tolerability of UCB7858 when given as single ascending doses administered by intravenous or subcutaneous infusion 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers who gave their written consent by signing the Informed Consent Form
- •Subjects in the age between 18 and 55 years old with normal weight as determined by a body mass index (BMI) between 18 and 30 kg/m^2, with a body weight of at least 50 kg for male subjects or 45 kg for female subjects
- •Subject has clinical laboratory test results within the reference ranges of the testing laboratory or outside the reference range of the laboratory but considered as not clinically significant by the Investigator
- •Subjects has blood pressure (BP) and pulse within normal range in a supine position after 5 minutes rest
- •Subject's electrocardiogram (ECG) is considered normal or abnormal but clinically non significant
- •Female subjects of childbearing potential must agree to use a highly effective method of birth control during the study and for a period of 6 months after dosing of IMP
排除标准
- •Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study: Subject has any acute or chronic illness which, in the opinion of the Investigator, may place the subject at risk because of participation in the study. Subject has any clinically relevant abnormal findings in physical examination, laboratory tests, vital signs, or ECG, which, in the opinion of the Investigator, may place the subject at risk because of participation in the study.
- •Tests positive for Human Immunodeficiency Virus (HIV)-1 or-2 antibodies, Hepatitis B Virus (HBV) surface antigen, or Hepatitis C Virus (HCV) antibody at Screening
- •Any of the following hematological function tests at the Screening Visit: Hemoglobin <111g/L (for women) or <113g/L (for men)
- •Absolute neutrophil count <1.5x10^9/L (<1000/mm^3); Platelets <150x10^9/L
- •Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 6 months following the final dose of the IMP
- •For subjects enrolled in the cohorts where the skin biopsies will be performed (Cohort 7 onward), the following exclusion criteria will also apply:
- •Subject has a known hypersensitivity to dressings, local anesthetics, suture material, or relevant local/oral antibiotic therapy
- •Subject has or had a history of a known inflammatory dermatological condition including eczema, atopic dermatitis, candidiasis, psoriasis, recurrent or persistent fungal infection, or bacterial infections
- •Subject uses steroid or nonsteroidal anti-inflammatory drug (NSAID)-containing skin creams on a regular basis
- •Subject has used NSAID or NSAID-containing medications within 7 days of randomization
- •Subject has used skin emollients within 7 days of randomization on the area of the skin from buttocks
- •Subject has tattoos, nevi, or other skin abnormalities such as keloids (or history of keloids, folliculitis, or acne vulgaris) that may, in the opinion of the Investigator, interfere with study assessments.
- •Subject has been participating in recreational sun-bathing, or use of sun-bed, on the area of the skin from buttocks within 7 days of Screening
- •Subject has active neoplastic disease or history of neoplastic disease within 5 years of the Screening Visit
- •Subject has a history of moderate to severe allergic reaction to medication(s) including biologics (for subjects in Cohort 11 only).
研究组 & 干预措施
UCB7858 (intravenous)
Experimental
Various single doses, administered to various cohorts.
干预措施: UCB7858 (Drug)
Placebo (intravenous)
Placebo Comparator
Single dose placebo comparator for each cohort of iv administration.
干预措施: Placebo (Drug)
Placebo (subcutaneous)
Placebo Comparator
Single dose placebo comparator for each cohort of sc administration.
干预措施: Placebo (Drug)
UCB7858 (subcutaneous)
Experimental
Various single doses, administered to various cohorts.
干预措施: UCB7858 (Drug)
结局指标
主要结局
Incidence of adverse events following administration of UCB7858
时间窗: Cohort 1-10: Day 1 up to Day 72 Cohort 11: Day 1 up to Day 120
次要结局
- Maximum plasma concentration (Cmax)(Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120)
- Time to reach Cmax (tmax)(Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120)
- Area under the curve from time 0 to time t, the time of last quantifiable concentration [AUC(0-t)](Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120)
- Area under the curve from 0 to infinity (AUC)(Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120)
- The terminal plasma half-life (t1/2) following intravenous administration(Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120)
- Plasma clearance (CL) of UCB7858 following intravenous administration(Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120)
- Volume of distribution (Vss) for UCB7858 at steady state following intravenous administration(Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120)
- Apparent volume of distribution (Vss/F) of UCB7858 following subcutaneous administration(Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120)
- Apparent plasma clearance (CL/F) of UCB7858 following subcutaneous administration(Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120)
- Mean absolute bioavailability (F) of UCB7858 given subcutaneously, using the ratio of geometric mean AUCs for subcutaneous (sc) administration and intravenous (iv) infusion (AUC_sc/AUC_iv)(Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120)
- Concentration of UCB7858 at the end of infusion (Cinf)(Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120)
- Time at the end of infusion of UCB7858 (tinf)(Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120)
研究者
研究点 (1)
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