NCT06006559招募中2 期
A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 32
- 主要终点
- Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start
研究概览
简要总结
The purpose of this study is to characterize the effect on dengue viral load, fever clearance time as well as on clinical signs and symptoms with the treatment of EYU688 compared with placebo in patients with dengue fever.
详细描述
This is a randomized, participant- and investigator- blinded, placebo-controlled study to investigate the efficacy and safety of EYU688 administered orally in patients with dengue fever.
Due to the different PK sampling schedules applied, the study consists of two cohorts run in parallel (intensive PK [cohort 1] and sparse PK sampling [cohort 2]).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 - 60 years old (inclusive).
- •History or presence of fever (≥ 38°C). At least one of the following criteria indicating dengue infection:
- •Nausea or vomiting.
- •Presence of rash, aches or pains including headache, muscle or joint pain.
- •Onset of fever ≤ 48 hours prior to treatment start.
- •Positive test on dengue fever.
排除标准
- •Participants with any of abnormalities of clinical laboratory parameters.
- •Usage of any anticoagulant drugs.
- •Current significant medical conditions or illness that the investigator considers should exclude the participants, especially those that require continuation of other medications likely to have an interaction with the study drug.
- •Pregnant or nursing (lactating) women.
- •Clinical signs and symptoms for severe dengue according to Dengue Guideline (WHO 2009) at screening.
- •Participants with any of the following abnormalities of clinical laboratory parameters at screening:
- •Hemoglobin <12.0 g/dL in males; <11.0 g/dL in females
- •Hematocrit >52 % in males; >46 % in females
- •Absolute neutrophil count <1500/μL
- •Platelet count <80,000/mm3
- •Creatinine >165 μmol/L in males; >130 μmol/L in females
- •Serum creatine kinase > 600 U/L
- •ALT, AST levels more than 3 X upper limit of normal (ULN)
- •Total bilirubin >24 μmol/L
- •Usage of PPIs (proton pump inhibitor) which could affect absorption of EYU688 due to stomach pH value increase up to 48 hours prior to screening.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 4 days after stopping of investigational drug.
- •History or long-QT syndrome, or clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening:
- •QTcF > 450 msec (males)
- •QTcF > 460 msec (females)
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
EYU688
Experimental
EYU688 administered by oral route
干预措施: EYU688 (Drug)
Placebo
Placebo Comparator
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start
时间窗: From predose to 48 hours post treatment start
Efficacy assessment of EYU688. It will allow to quantify the viremia reduction at 48 hours post treatment start from baseline.
次要结局
- Requiring fluid infusion(From inclusion to Day 15)
- Time from fever onset to start of the first 48 hours period during which the oral temperature remained below 37.5℃(From fever onset to Day 15)
- Time from fever onset to the first of two consecutive negative viremia by PCR(From fever onset to Day 15)
- Area under the log-transformed viremia curve (AUC) from the first dose to Day 15(From fever onset to Day 15)
- Changes of viral load over time(From baseline to Day 15)
- Incidence and severity of Adverse Events (AEs)(From inclusion to Day 15)
- Incidence and severity of Serious Adverse Events (SAEs)(From inclusion to Day 35)
- Change of white blood cell count over time from baseline(From baseline to Day 15)
- Change of platelet count over time(From baseline to Day 15)
- Change of hematocrit level and percentage increase from baseline over time(From baseline to Day 15)
- Change of AST, ALT levels over time(From baseline to Day 15)
- No warning signs by day 7 of fever onset(From inclusion to Day 15)
- Diagnosis of severe dengue fever(From inclusion to Day 15)
- Diagnosis of dengue hemorrhagic fever (DHF)(From inclusion to Day 15)
- Plasma leakage(From inclusion to Day 15)
- Time from fever onset to clinical recovery(From fever onset to Day 15)
- PK parameter (Cmax)(From Day 1 to Day 6)
- PK parameter (Tmax)(From Day 1 to Day 6)
- PK parameter (partial AUCs)(From Day 1 to Day 6)
- PK concentrations following multiple doses(From Day 1 to Day 6)
研究者
研究点 (32)
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