ACTRN12619000465156已完成1 期
Bioequivalence double-blind, randomized, two-parallel-group phase 1 study of a humanised anti-immunoglobulin E monoclonal antibody BP001 as Lyophilized Powder Formulation Compared with the Standard Omalizumab (Xolair®) Lyophilized Powder Formulation in healthy male volunteers
Biosana Pty Ltd0 个研究点目标入组 84 人开始时间: 2019年3月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
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 55 Years（—）
- 性别
- Male
入选标准
- •1.Male aged 18 to 55 years, inclusive;
- •2.Body mass index (BMI) between 18 and 30 kg/m2 inclusive, with a minimum weight of 50 kg and a maximum of 100 kg;
- •3.Healthy as determined by pre-study medical history, physical examination (PE), vital signs, and 12-lead electrocardiogram (ECG);
- •4.Negative tests for Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) and human immunodeficiency virus HIV-1and HIV-2 antibody at screening;
- •5.Normal blood chemistry values, or any abnormalities should be not clinically significant, as determined by the investigator at screening and Day -1. Serum IgE < 100 U/ml will be assessed for eligibility at screening only. Lab tests may be repeated once at the discretion of the investigator;
- •6.Negative screen for alcohol and drugs of abuse at screening and admission; Drugs of abuse may be repeated at the discretion of the investigator to account for a false positive ie. where a participant has consumed poppy seeds;
- •7. Must be practicing a highly effective method of birth control with female partners of childbearing potential from screening throughout the study and for at least 90 days after the investigational drug administration. Highly effective birth control methods include vasectomy, abstinence or condom use in combination with partner’s use of highly effective contraception (i.e. hormonal contraceptives including oral, patch, vaginal ring, implant or injection, intra uterine device (IUD), or documented evidence of surgical sterilization at least 6 months prior to screening visit (i.e. tubal ligation or hysterectomy). Subjects with same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle.
排除标准
- •1.Unwillingness or inability to follow the procedures outlined in the protocol;
- •2.Positive drug screen at Screening or Day -1;
- •3.Have a history of drug abuse;
- •4.History of alcohol abuse;
- •5.Regular smokers within 2 months prior to screening. Social smokers (Less than or equal to 10 cigarettes/week) may be included if they agree to abstain for the duration of the trial;
- •6.Participation in studies with monoclonal antibody therapy within 6 months of Screening or previous exposure to omalizumab;
- •7.Participated in any other investigational clinical study in which administration of an investigational study drug occurred within 30 days or 5 half-lives of the product (whichever is the longest) prior to Screening;
- •8.History of clinical relevant history of allergy related diseases including hay fever, urticaria, allergic asthma, allergic rhinitis; Mild allergic conditions may be included at the discretion of the Investigator;
- •9.History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator, contraindicates their participation;
- •10.Any concurrent disease, physical and/or mental condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results;
- •11.Subjects with surgical or medical conditions that may significantly alter the absorption form subcutaneous tissue, distribution, metabolism or excretion of omalizumab.
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