ACTRN12613000618752撤回1 期
A Safety and Tolerability Study in malaria naive humans for Tafuramycin-A attenuated Plasmodium falciparum NF54 blood stage parasites.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 6
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 60 Years（—）
- 性别
- Male
入选标准
- •1. Males aged 18-60 years of age who do not live alone for the duration of the study.
- •2. Body mass index within range 18-30.
- •3. Contactable and available for the duration of the trial (90 days).
- •4. Non-smokers and in good health as assessed during pre-study medical examination and by review of screening results.
- •5. Good peripheral vein access.
排除标准
- •1. Has increased cardiovascular disease risk (defined as >10%, 5 yr risk) as determined by the method of Gaziano et al. Risk factors include: sex, age, systolic blood pressure, smoking status, body mass index (BMI, kg/mm2), and reported diabetes status and blood pressure.
- •2. History of splenectomy
- •3. History of severe allergic reaction, anaphylaxis or convulsion following any vaccination, infusion or treatment with anti-malarial drugs artemether and/or lumefantrine.
- •4. Presence of current or suspected chronic diseases such as cardiac or autoimmune disease (HIV or other immunodeficiencies), insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, psoriasis, rheumatoid arthritis, asthma, epilepsy, obsessive compulsive disorder, skin carcinoma excluding non-spreadable skin cancers such as basal cell and squamous cell carcinoma.
- •5. Known inherited genetic anomaly (known as cytogenic disorders) eg Down’s syndrome.
- •6. Individuals wishing to donate blood to the Australian Red Cross Blood Service in the future.
- •7. The volunteer has a diagnosis of schizophrenia, bi-polar disease, severe depression or other severe (disabling) chronic psychiatric disorder. Participants who are receiving a single anti-depressant drug and are stable for at least 3 months prior to enrollment without decompensating may be allowed to enroll in the study at the investigator’s discretion.
- •8. Has been hospitalised in the past 5 years prior to enrolment for psychiatric illness, history of suicide attempt or confinement for danger to self or others.
- •9. Known pre-existing prolongation of the QTc interval. Family history of congenital prolongation of the QTc interval on electrocardiograms or of sudden death or any other clinical conditions known to prolong the QTc interval eg volunteers with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
- •10. Recent or current therapy with antibiotic or drug with potential antimalarial activity (tetracycline, azithromycin, clindamycin, hydroxychloroquine etc).
- •11. Concomitant use of any drug which is metabolized by the cytochrome enzyme CYP2D6 (eg flecainide, metoprolol, imipramine, amitriptyline, clomipramine) OR drugs that are known to prolong the QTc interval e.g. antiarrhythmics of classes IA and III, neuroleptics, antidepressant agents, certain antibiotics (including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents), certain nonsedating antihistamines (terfenadine, astemizole), cisapride.
- •12. Use of corticosteroids, anti-inflammatory drugs, any immunomodulators or anticoagulants. Currently receiving or have previously received immunosuppressive therapy, including systemic steroids including ACTH or inhaled steroids in dosages which are associated with hypothalamic-pituitary axis suppression such as 1mg/kg/day or prednisone or its equivalent or chronic use of inhaled high potency corticosteroids (budesonide 800 micrograms per day or fluticasone 750 micrograms).
- •13. Presence of acute infectious disease or fever (e.g. sub-lingual temperature greater than or equal to 38.5 degrees celsius) within the five days prior to the study product administration.
- •14. Evidence of acute illness within the 4 weeks before trial prior to screening.
- •15. Significant intercurrent disease of any type, i
研究者
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