NCT03899142已完成1 期
Pharmacokinetics of HepBQuin Manufactured According to a New Production Process
Prothya Biosolutions1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年3月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- half-life of anti-HBs antibodies
研究概览
简要总结
Sanquin Plasma Products BV developed a new manufacturing process for the Quin plasma products in order to improve viral safety and to remove procoagulant activity. Since the new manufacturing process will be the same for all Quin products, a clinical study with one of the Quin products is sufficient for marketing authorisation of all new Quin products. HepBQuin will serve as model for all other Quin products. Pharmacokinetic (PK) data are considered as a surrogate indicator of efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Healthy volunteers, male and female, aged 18 to 65 inclusive.
- •Negative serology test for HBsAg, anti-HBs, and anti-HBc at screening.
- •Body-mass index (BMI) of 18.5 to 32.0 kg/m2 (inclusive).
- •Female volunteers must have a pregnancy test at screening.
- •Willing to participate by signing the written signed informed consent form.
排除标准
- •Vaccinated against Hepatitis B
- •Having a Hepatitis B infection or suffered from a Hepatitis B infection in the past.
- •Known with allergic reactions against human plasma, plasma products or blood products.
- •A history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening.
- •Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- •Known with or having a history of arterial or venous thromboembolic events.
- •Pre-existing risk factors for thrombotic events.
- •Any clinically significant history of or current clinically significant other disease or disorder.
- •Any clinically significant abnormality following the investigator's review of physical examination, and clinical laboratory tests obtained at screening.
- •An abnormal pulse rate and/or blood pressure measurements at the screening visit.
- •Pregnant or breast-feeding at screening or at Day 0
- •Women of childbearing potential not using a highly effective method of birth.
- •Any use of drugs or abuse within 3 months prior to screening and during study.
- •Alcohol abuse within 3 months prior to screening and during study
- •Participated in another interventional clinical trial a month before the start of the study, or having received an experimental drug during the previous 30 days.
- •Having IgA deficiency with anti-IgA antibodies.
- •Blood or plasma donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial.
研究组 & 干预措施
human hepatitis B immunoglobulin
Experimental
once, i.m.
干预措施: a human hepatitis B immunoglobulin solution for injection for intramuscular administration (Biological)
结局指标
主要结局
half-life of anti-HBs antibodies
时间窗: 84 days
Pharmacokinetics
次要结局
- number of adverse events(84 days)
研究者
研究点 (1)
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