A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever

Официальное название

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

Обзор

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.

Подробное описание

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 \[cohort 2\]).

Вмешательства

• Препарат EYU688
  EYU688 administered by oral route
• Препарат Placebo
  Matching placebo administered orally as capsules

Первичные конечные точки

• Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start [Срок оценки: From predose to 48 hours post treatment start]

Вторичные конечные точки (12)

• Time from fever onset to start of the first 48 hours period during which the oral temperature remained below 37.5℃ [Срок оценки: From fever onset to Day 15]
• Time from fever onset to the first of two consecutive negative viremia by PCR [Срок оценки: From fever onset to Day 15]
• Area under the log-transformed viremia curve (AUC) from the first dose to Day 15 [Срок оценки: From fever onset to Day 15]
• Changes of viral load over time [Срок оценки: From baseline to Day 15]
• Incidence and severity of Adverse Events (AEs) [Срок оценки: From inclusion to Day 15]
• Incidence and severity of Serious Adverse Events (SAEs) [Срок оценки: From inclusion to Day 35]
• Change of white blood cell count over time from baseline [Срок оценки: From baseline to Day 15]
• Change of platelet count over time [Срок оценки: From baseline to Day 15]
• Change of hematocrit level and percentage increase from baseline over time [Срок оценки: From baseline to Day 15]
• Change of AST, ALT levels over time [Срок оценки: From baseline to Day 15]
• No warning signs by day 7 of fever onset [Срок оценки: From inclusion to Day 15]
• Diagnosis of severe dengue fever [Срок оценки: From inclusion to Day 15]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 6 центров

• Novartis Investigative Site — Manaus
• Novartis Investigative Site — Brasília
• Novartis Investigative Site — Rio de Janeiro
• Novartis Investigative Site — Rio Grande
• Novartis Investigative Site — Sorocaba
• Novartis Investigative Site — Sao Jose Rio Preto

Индия · 5 центров

• Novartis Investigative Site — Belagavi
• Novartis Investigative Site — Mumbai
• Novartis Investigative Site — Pune
• Novartis Investigative Site — Jaipur
• Novartis Investigative Site — Chennai

Малайзия · 5 центров

• Novartis Investigative Site — Kuantan
• Novartis Investigative Site — Ipoh
• Novartis Investigative Site — Seberang Jaya
• Novartis Investigative Site — Miri
• Novartis Investigative Site — Kuala Selangor

Колумбия · 3 центра

• Novartis Investigative Site — Barranquilla
• Novartis Investigative Site — Bucaramanga
• Novartis Investigative Site — Cali

Вьетнам · 3 центра

• Novartis Investigative Site — Haiphong
• Novartis Investigative Site — Hanoi
• Novartis Investigative Site — Ho Chi Minh City

Сингапур · 2 центра

• Novartis Investigative Site — Singapore
• Novartis Investigative Site — Singapore

Публикации

• Bouzidi HS, De Lamballerie X, Touret F. Therapeutic approaches against dengue virus: current status of vaccines, antivirals, and monoclonal antibodies. Emerg Microbes Infect. 2026 Dec;15(1):2686471. doi: 10.1080/22221751.2026.2686471. Epub 2026 Jun 21. PMID 42253092

Идентификаторы

NCT: NCT06006559 · CEYU688A12201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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