PACTR202408719575384尚未招募1 期
First-in-human, single center, open-label, dose-escalation phase 1 study in healthy non-malaria adults to evaluate the safety and pharmacokinetic parameters of unidose UDSp intranasal spraying of artesunate.
niversity of sciences techniques and technologies of Bamako0 个研究点目标入组 12 人开始时间: 2024年7月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- All
入选标准
- •Potential subjects are required to meet all of the following criteria for enrollment into the study:
- •Healthy adults between the ages 18-25 (inclusive);
- •Able and willing to provide written, informed consent;
- •Able and willing to comply with all research requirements, in the opinion of the Investigator;
- •Axillary temperature < 37.5°C
- •Laboratory Criteria within 10 days before enrollment:
- •Hemoglobin = 11.7 g/dL for women; = 12.0 g/dL for men;
- •White Blood Cell count = 3,800-10,800 cells/mm3;
- •Platelets = >140,000/mm
排除标准
- •Subjects meeting any of the following criteria are not eligible for inclusion in this study.
- •1.Ages < 18 or > 25;
- •2.Pregnant or lactating female
- •3.Not able or not willing to provide written, informed consent;
- •4.Signs and symptoms of severe or non-severe malaria according to WHO 2015 criteria
- •5.Active infections including tuberculosis
- •6.Axillary temperature = 37.5°C
- •7.Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- •8.Severe malnutrition (body mass index (BMI) less than 70% of median normalized WHO reference weight)
- •7.Severe vomiting (defined as more than 3 times in the 24 hours prior to inclusion in the study) or severe diarrhea (defined as more than 3 watery stools in the 24 hours prior to inclusion in the study)
- •8.Anemia (Hemoglobin level < 11.7 g/dL)
- •9.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
- •10.Known chronic underlying disease such as sickle cell disease, and severe cardiac, renal, or hepatic impairment
- •11.Known active or uncontrolled ear, nose and throat (ENT) disease
- •12.Inability to tolerate oral medication (in tablet and/or liquid form)
- •13.Patients with prior antimalarial therapy within minimum of 4 weeks
- •14.Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer
- •15.History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia or severe heart disease
- •16.History of hypersensitivity to artesunate and dihydroartemisinin, or its excipients or to drugs of similar chemical classes
研究者
相似试验
已完成
不适用
A phase 1, first-in-human, multicenter, open-label, dose-escalation study to characterize the safety and tolerability of MP0317 in patients with relapsed/refractory advanced solid tumorsNL-OMON51895Molecular Partners AG30
招募中
不适用
A Phase I, first-in-human, multicenter, open-label, dose escalation followed by an expansion phase clinical study of KBA1412 given as monotherapy or in combination with pembrolizumab in adults with advanced solid malignant tumorsmelanomaSolid Tumors10018865NL-OMON53468Kling Biotherapeutics B.V.22
进行中（未招募）
1 期
A clinical trial that is optimising 2 radioactive anti-cancer treatments to see if the combination is safe and effective for patients with a form of brain cancer known as GBM.2nd line therapy of recurrent GBM (Glioblastoma multiforme), scheduled for repeat XRT.EUCTR2018-002262-39-ATTELIX International Pty Ltd44
进行中（未招募）
1 期
A clinical trial that is optimising 2 radioactive anti-cancer treatments to see if the combination is safe and effective for patients with a form of brain cancer known as GBM.2nd line therapy of recurrent GBM (Glioblastoma multiforme), scheduled for repeat XRT.EUCTR2018-002262-39-NLTELIX International Pty Ltd44
进行中（未招募）
1 期
An early stage study looking at how much betrixaban gets into the blood of young people after they take a single capsule, and to see if it is safe to do so.Pediatric patients who are assessed to be at risk for Venous thromboembolism (VTE) but does not require immediate anticoagulant therapy, for example:a. Has previous thrombosis and completed a course of anti-coagulant therapy, and is considered to have a risk for recurrence of VTE, orb. Has any stable disease with a risk for arterial or venous thrombotic disorder, orc. Has any functional CVAD (Central Venous Access Device) in the upper or lower venous system.MedDRA version: 20.0Level: PTClassification code 10053468Term: Anticoagulant therapySystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2018-002562-40-GBPortola Pharma UK Ltd33