ACTRN12619001399189已完成1 期
A randomized, double-blind, 2-treatment, 2-period, crossover phase I study to compare the pharmacokinetics, safety and tolerability of 60 IU/kg of Abcertin, and EU-sourced Cerezyme® in healthy volunteers following a single intravenous administration.
ISU Abxis Co., LTD0 个研究点目标入组 42 人开始时间: 2019年10月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •(1)Subject must be able to give voluntary written informed consent prior to any study-related procedures.
- •(2)Subject must have availability for the entire study period.
- •(3)Male or female subjects aged 18 years to 45 years inclusive.
- •(4)Body mass index (BMI) greater than or equal to 18.5 and less than or equal to 30.0 kg/m2 (Weight 55-105 kg, inclusive).
- •(5)Female subjects of childbearing potential must be non-pregnant and non-lactating, and have a negative pregnancy test at Screening, and at (each) admission to the clinical research center.
- •(6)Females of childbearing potential, with a fertile male sexual partner, must use adequate contraception from Screening until 90 days after the follow-up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least one of the following forms of contraception: a diaphragm or cervical cap, or a condom.
- •(7)Males must use adequate contraception and must not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject and his female partner, is defined as using hormonal contraceptives or an intrauterine device combined with at least one of the following forms of contraception: a diaphragm or cervical cap, or a condom.
- •(8)Subject must be healthy as determined by clinical Investigator, based on medical history, physical examination, 12-lead ECG, and laboratory evaluations (hematology, clinical chemistries, coagulation, and urinalysis tests).
- •(9)All values for clinical laboratory tests of blood and urine should not be clinically significant as judged by the Principal Investigator.
排除标准
- •(1)Intake of any investigational drug in another study within 30 days (or 5 half-lives, whichever is greater) prior to intake of IMP in this study or have received the last dose of a study drug more than 30 days ago (or 5 half-lives, whichever is greater) but who are on extended follow-up, or planned intake of an investigational drug (other than for this study) during the course of this study.
- •(2)With ongoing symptoms indicating acute diseases within 28 days prior to dosing of IMP; Acute disease refers to any new onset of symptoms/signs or diagnosis of disease whether infectious, inflammatory, traumatic, etc. in origin (regardless whether the subject was hospitalized or not).
- •(3)With any medical history that may affect drug distribution, metabolism and excretion (e.g., hepatic or renal disease).
- •(4)Positive screen on hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibodies or anti-HIV 1 and 2 antibodies. If a potential subject is considered by Investigator to have false positive result (ex. HIV antibodies) at screening, then a repeat test should be done as soon as possible and if retest is negative, the subject can be considered eligible for the study.
- •(5)Clinically significant hypersensitivity, or severe allergic reactions (either spontaneous or following IMP administration), also including known or suspected clinically relevant drug hypersensitivity to any components of the IMP or comparable drugs, including Latex.
- •(6)Vaccination with a live vaccine within 3 months prior to the first dosing of IMP or planning a vaccination with a live vaccine before the follow-up visit.
- •(7)With the results of safety laboratory test
- •a.AST (sGOT) or ALT (sGPT) > 1.5 times of upper normal limit, or
- •b.Total bilirubin > 1.5 times of upper normal limit
- •Note: Safety laboratory tests can be repeated if the subject is clinically asymptomatic in relation to abnormal result and Investigator strongly believes this is not clinically significant. One re-test is allowed. If the result still meets the exclusion criteria, subject will be excluded.
- •(8)Subject who has immune deficiency or medication with immunosuppressive agents.
- •(9)Treatment with any medication prescribed or over-the-counter (OTC) products including herbal remedies within 14 days prior to Day 1 or longer if the medication has a long half-life, unless agreed as not clinically significant by the Investigator and Sponsor. Exceptions: hormonal contraceptives, acetaminophen less than or equal to 3 g/day, vitamins at daily recommended doses.
- •(10)Donated whole blood products (e.g., plasma, platelets) within 60 days, or transfused within 20 days before Screening.
- •(11)History of alcohol or drug abuse or drug addiction (including cannabis products) within the last 12 months before Screening.
- •(12)Subject is unwilling to comply with the alcohol restrictions. The subject should refrain from drinking any alcohol within 72 hours prior to Day -1, and should not consume more than 3-4 units of alcohol per day to a maximum of 14 units of alcohol per week (1 unit of 10 mL of pure alcohol, 12 ounces [360 mL] of beer, 5 ounces [150 mL] of wine, or 1.5 ounces [45 mL] of 80 proof distilled spirits) throughout the study.
- •(13)Heavy smoker (> 5 cigarettes/day) or the subject could not stop smoking during study period while inpatient at the clinical research center.
- •(14)Positive tests for drugs of abuse or alcohol at Screening or admission to the study site (Day -1).
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