ISRCTN17423851已完成1 期
A first-in-human, single-centre, single ascending dose, multiple-dose and pilot food effect study to assess the safety, tolerability and pharmacokinetics of MMV367 in healthy participants
Medicines for Malaria Venture0 个研究点目标入组 72 人开始时间: 2022年6月24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
- 72
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
- 性别
- All
入选标准
- •Informed consent and compliance:
- •1. Must provide written informed consent
- •2. Must be willing and able to communicate and participate in the whole study
- •Demographics and contraception:
- •3. Aged 18 to 55 years inclusive at the time of signing the informed consent
- •4. Must agree to adhere to the contraception requirements
- •Baseline characteristics:
- •5. Healthy males or non-pregnant, non-lactating healthy females.
- •6. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening
- •7. Weight =50 kg at screening
排除标准
- •1. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- •3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- •4. Blood pressure (supine) at screening or admission outside the range of 90 to 140 mmHg systolic or 50 to 90 mmHg diastolic; and pulse rate outside the range of 45 to 100 bpm, unless deemed not clinically significant by the investigator
- •5. A decrease of SBP = 20 mmHg after 3 min standing and/or a decrease of DBP =10 mmHg after 3 min standing, at screening
- •6. History or presence of known structural cardiac abnormalities, family history of long QT syndrome, cardiac syncope or recurrent, idiopathic syncope, exercise-related clinically significant cardiac events. Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG or clinically important abnormalities that may interfere with the interpretation of QT interval changes
- •7. Presence of sinus node dysfunction, clinically significant PR interval prolongation (>210 msec), intermittent second- or third-degree atrioventricular block, complete bundle branch block, sustained cardiac arrhythmias including (but not limited to) atrial fibrillation or supraventricular tachycardia; any symptomatic arrhythmia with the exception of isolated extra systoles, abnormal T wave morphology which may impact on the QT/QTc assessment, or QTcF >450 msec. Participants with borderline abnormalities may be included if the deviations do not pose a safety risk, and if agreed between the sponsor’s medical monitor and the investigator
- •8. Participants with a history of cholecystectomy or gall stones
- •9. Participants with conditions that affect their ability to smell or taste including, but not limited to mouth ulcers, gum disease, nasal surgery and smell and/or taste disorders (e.g. dysosmia, dysgeusia, respiratory and/or sinus infection or cold). Part 1 only.
- •10. Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- •11. Evidence of current SARS-CoV-2 infection
- •12. Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator Participants with Gilbert’s Syndrome are not allowed.
- •13. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- •14. Females who are pregnant or lactating (all female participants must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test at admission)
- •15. Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- •16. Participants who have previously been administered IMP in this study. Participants who have taken part in Part 1 are not permitted to take part in Parts 2 and 3 and participants who have taken part in Part 2 are not permitted to take part in Part 3
- •17. Donation of blood or plasma within the previous 3 months or loss of greater than 400 ml of blood
- •18. Participants who are taking, or have taken, any prescribed or
研究者
相似试验
已完成
1 期
First in human clinical study of a novel drug JNT-517 to assess its safety and tolerability in healthy volunteersPhenylketonuriaACTRN12622001222730CTI Clinical Trial and Consulting Services Australia Pty Ltd.72
招募中
1 期
The Tetherx Natural Vascular Scaffolding (NVS) Procedure for Treating Patients with Atherosclerosis of the Femoropopliteal ArteryACTRN12611000897965Tetherx, Inc.30
已完成
不适用
A single-center, single-arm, retrospective pivotal trial to evaluate the efficacy of artificial intelligence-based fundus photography analysis software.KCT0004902Vuno1,713
进行中（未招募）
1 期
A single-center study to assess the effect of lamivudine (3TC) on cognitive impairment (alterations in thinking, learning, memory...) by the analysis of the plasma of patients with Mild Cognitive Impairment (MCI)Mild Cognitive impairment due to Alzheimer DiseaseMedDRA version: 27.0Level: LLTClassification code: 10090501Term: Mild cognitive impairment Class: 100000004852MedDRA version: 21.1Level: LLTClassification code: 10009846Term: Cognitive impairment Class: 10029205MedDRA version: 20.0Level: LLTClassification code: 10001896Term: Alzheimer's disease Class: 10029205CTIS2024-514330-20-00Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia25
进行中（未招募）
1 期
A first-in-human study of HMB-001 in patients with Glanzmann thrombastheniaGlanzmann thrombastheniaISRCTN66310879Richmond Pharmacology Ltd57