NCT07235020已完成2 期
A Multi-part, Multi-center PLATform Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Anti-malarial Agents Administered as Monotherapy and/or Combination Therapy IN Participants With Uncomplicated Plasmodium Falciparum Malaria
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Parasite clearance time (PCT)
研究概览
简要总结
This is Cohort A1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 in participants with uncomplicated Plasmodium falciparum malaria.
详细描述
The Cohort A1 of this Platfom study (NCT05750628) is an open-label, randomized, multi-arm monotherapy part evaluating a single oral administration of an anti-malarial agent (INE963) at 3 parallel dose levels followed by optional adaptive sequential dose level(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study is open-label study.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ≥18 years of age at screening.
- •Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150,000 asexual parasite count/μl of blood for P. falciparum
- •Patients must weigh between 40 kg and 90 kg.
- •Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
排除标准
- •Patients with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening
- •Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level < 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
- •Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening:
- •AST/ALT > 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
- •AST/ALT > 1.5 and ≤ 2 x ULN and total bilirubin is > ULN
- •Total bilirubin > 2 x ULN, regardless of the level of AST/ALT
- •Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
- •Pregnant or nursing (lactating) women, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of effective contraception, and sexually active patients not willing to practice effective contraception.
- •History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:
- •Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
- •History of familial long QT syndrome or known family history of Torsades de Pointe.
- •Resting heart rate (physical exam or 12 lead ECG) < 50 bpm
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Cohort A1: INE963 Dose Level 1
Experimental
Cohort A1: INE963 Dose Level 1
干预措施: INE963 (Drug)
Cohort A1: INE963 Dose Level 2
Experimental
Cohort A1: INE963 Dose Level 2
干预措施: INE963 (Drug)
Cohort A1: INE963 Dose Level 3
Experimental
Cohort A1: INE963 Dose Level 3
干预措施: INE963 (Drug)
Cohort A1: INE963 Dose Level 4
Experimental
Cohort A1: INE963 Dose Level 4
干预措施: INE963 (Drug)
结局指标
主要结局
Parasite clearance time (PCT)
时间窗: up to Day 7
To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in participants with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.
次要结局
- PCR-corrected and uncorrected ACPR(Day 29)
- Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)(Day 22)
- Area under the concentration-time curve from time zero to infinity (AUCinf)(Day 22)
- Elimination half-life (T1/2)(Day 22)
- Apparent volume of distribution (V/F)(Day 22)
- Maximum observed concentration (Cmax)(Day 22)
- Time to reach maximum observed concentration (Tmax)(Day 22)
- Total body clearance (CL/F)(Day 22)
- Area under the concentration-time curve (AUC0-t)(Day 22)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRCMetastatic Colorectal CancerNCT04952753Novartis Pharmaceuticals204
招募中
1 期
A Study to Evaluate INCA035784 in Participants With Myeloproliferative NeoplasmsNCT07008118Incyte Corporation120
尚未招募
4 期
Inetetamab Combined With Anti-PD-1 Monoclonal Antibody and Albumin-Bound Paclitaxel for HER2+ Metastatic Breast CancerBreast CancerNCT05291910Chinese Academy of Medical Sciences70
已完成
3 期
A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)Plaque PsoriasisNCT02368210Therapeutics, Inc.151
尚未招募
不适用
A multi center, phase 3 study to evaluate safety and efficacy of extensive intraoperative peritoneal lavage, that project to prevent recurrence, in the laparoscopic surgery for advanced colon cancerJPRN-UMIN000048457Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group2,600