ACTRN12617001502325已完成1 期
Apheresis of healthy subjects with induced blood stage Plasmodium vivax
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1.Adult (male and non-pregnant, non-lactating female) subjects between 18 and 55 years of age, inclusive who do not live alone (from Day 0 until at least the end of the anti-malarial drug treatment) and will be contactable and available for the duration of the trial and up to 2 weeks following end of study visit.
- •2.Body mass index between 18.0 and 32.0 kg/m2, inclusive and a minimum body weight of 50 kg.
- •3.Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- •4.Normal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position.
- •5.Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects enrolled in this study.
- •6.As there is the risk of adverse effects with artemether/lumefantrine and chloroquine in pregnancy, it is important that any subjects involved in this study do not get pregnant.
- •7.All subjects must be Duffy Blood group positive and have blood type O. Female subjects of childbearing potential should be blood group Rh positive.
排除标准
- •1.Any history of malaria or participation in a previous malaria challenge study.
- •2.Must not have travelled to or lived (greater than 2 weeks) in a malaria-endemic region during the past 12 months or planned travel to a malaria-endemic region during the course of the study.
- •3.Has evidence of increased cardiovascular disease risk.
- •4.History of splenectomy.
- •5.Presence or history of drug hypersensitivity, or allergic disease diagnosed by an allergist/immunologist and/or treated by a physician for allergy or history of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
- •6.Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immuno-deficiencies), insulin-dependent and non-insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, porphyria, psoriasis, rheumatoid arthritis, asthma, epilepsy, or obsessive compulsive disorder.
- •7.Frequent headaches and/or migraines, recurrent nausea, and/or vomiting (more than twice a month).
- •8.Presence of acute infectious disease or fever (e.g., sub-lingual temperature greater than or equal to 38.5 Degrees Celcius) within the 5 days prior to inoculation with malaria parasites.
- •9.Evidence of acute illness within the 4 weeks prior to screening that the Investigator deems may compromise participant safety.
- •10.Participant has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion (e.g. gastrectomy, diarrhoea).
- •11.Participation in any investigational product study within the 12 weeks preceding the study.
- •12.Blood donation, any volume, within 1 month before inclusion, or participation in any research study involving blood sampling (more than 450 mL/unit of blood), or blood donation to the Australian Red Cross Blood Service (Blood Service) or other blood bank during the 8 weeks preceding the treatment drug dose in the study.
- •13.Participant who has ever received a blood transfusion.
- •14.Any vaccination within the last 28 days.
- •15.Any recent ( less than 6 weeks) or current systemic therapy with an antibiotic or drug with potential anti-malarial activity (i.e. chloroquine, piperaquine, benzodiazepine, flunarizine, fluoxetine, tetracycline, azithromycin, clindamycin, doxycycline etc.).
- •16.Cardiac/QT risk.
- •17.Known hypersensitivity to artemether/lumefantrine or chloroquine or any of thier excipients, or 4-aminoquinolines, artemether or other artemisinin derivatives, lumefantrine, piperaquine.
研究者
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