An Open Label, Single Dose Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum Malaria Mono-infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- 28-day Cure Rate
研究概览
简要总结
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day
详细描述
the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study.
cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. After approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 20 to 60 years
- •Presence of mono-infection of P. falciparum
- •Weight between 40 kg to 90 kg
排除标准
- •Patients with signs and symptoms of severe/complicated malaria
- •Mixed Plasmodium infection
- •Presence of other serious or chronic clinical condition requiring hospitalization.
- •Severe malnutrition
- •Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study
研究组 & 干预措施
Cohort 1
6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
干预措施: KAE609 (Drug)
Cohort 2
6-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose
干预措施: KAE609 (Drug)
Cohort 3
6 to 12 subjects with Plasmodium falciparum malaria will receive 225 mg KAE609 as a single dose
干预措施: KAE609 (Drug)
Cohort4
6- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose
干预措施: KAE609 (Drug)
结局指标
主要结局
28-day Cure Rate
时间窗: Day 28
28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).
次要结局
未报告次要终点