2022-501985-23-00已完成1 期
A Phase 1, Multicentre, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single IV Dose of Rezafungin Acetate in Paediatric Subjects from Birth to <18 Years of Age, Receiving Systemic Antifungals as Prophylaxis for Invasive Fungal Infection or to Treat a Suspected or Confirmed Fungal Infection
Mundipharma Research Limited, Mundipharma Research Limited6 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2023年4月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Parts 1 and 2: The following PK parameters will be assessed: Cmax, Tmax, AUC0-t, AUC0-∞, CL, Vss, Vz, t1/2
研究概览
简要总结
To evaluate the pharmacokinetics (PK) of a single IV dose of rezafungin in paediatric subjects from birth to <18 years, receiving concomitant systemic antifungals as prophylaxis for invasive fungal infection (IFI) or to treat a suspected or confirmed fungal infection
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Part 3
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female paediatric subjects from birth to <18 years of age who are receiving concomitant systemic antifungals (oral or IV) as prophylaxis for IFI or to treat a suspected or confirmed fungal infection.
排除标准
- •History of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals and/or excipients of this formulation;
- •Previous or current medical conditions of severe ataxia, persistent tremors, intracranial haemorrhage or neuropathy, or a diagnosis of epilepsy, multiple sclerosis, or a movement disorder (including, but not limited to, cerebral palsy and muscular dystrophy);
- •Subjects with impaired renal or hepatic functions (alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of normal, conjugated bilirubin >24 µmol/L [1.4 mg/dL], serum creatinine >177 µmol/L [2 mg/dL], or receiving renal replacement therapy);
- •Subjects with intestinal hypoxia, ischaemia, necrosis, or necrotising enterocolitis;
- •Subject status is unstable (e.g., with sepsis or disseminated intravascular coagulation), and subject is unlikely to complete required study procedures;
- •Participation in another interventional treatment trial with an investigational agent or presence of an investigational device at the time of informed consent or within 28 days preceding the informed consent.
结局指标
主要结局
Parts 1 and 2: The following PK parameters will be assessed: Cmax, Tmax, AUC0-t, AUC0-∞, CL, Vss, Vz, t1/2
Parts 1 and 2: The following PK parameters will be assessed: Cmax, Tmax, AUC0-t, AUC0-∞, CL, Vss, Vz, t1/2
Part 3: Rezafungin plasma concentrations
Part 3: Rezafungin plasma concentrations
次要结局
- The safety evaluation will be based on clinical review of the following parameters: • Incidence of treatment-emergent adverse events (TEAEs) • Clinical laboratory evaluations (including haematology, blood chemistry and urinalysis) • Vital signs • 12-lead electrocardiograms (ECGs): clinically significant abnormalities • Physical examination findings
研究者
Gu-Lung Lin
Scientific
Mundipharma Research Limited
研究点 (6)
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