A First-in-Human, Randomized, Dose-escalation, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, and Pharmacokinetics of BAL2420 Administered to Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Number of participants with abnormal electrocardiograms QT Interval in Part A
研究概览
简要总结
BAL2420 (also known as BAL0302420) is being developed as an antibacterial agent for the treatment of severe infections caused by Gram-negative bacteria. In this study, the sponsor aims to investigate the safety, tolerability and pharmacokinetics (PK) of BAL2420 following administration of single ascending doses (Part A) and multiple ascending doses (Parts B and C) in healthy adult volunteers. In all parts of the study, in each cohort, a different dose of study drug is to be investigated against a matched placebo in a randomized and double-blind manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index: 18.0 to 30.0 kg/m2, inclusive, at screening
- •Total body weight: > 50 kg at screening
排除标准
- •Any uncontrolled or active major systemic disease,
- •Active infection
- •Acute illness within 5 days prior to the first study drug administration that, in the opinion of the Investigator, may impact safety assessments.
- •Clinically-significant physical examination, vital signs, laboratory safety tests, or ECG abnormalities
- •History of risk factors for QT prolongation or Torsades de Pointes
- •QTcF (Fridericia's corrected QT interval) > 450 msec (males) and > 470 msec (females) at screening.
- •Receipt of prescribed medication other than hormonal contraceptives within the 30 days prior to admission to the clinical site.
- •Receipt of over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) within 14 days prior to admission to the clinical site.
- •History of relevant drug and/or food allergies, particularly to antibiotics.
- •History of tobacco use or e-cigarette within the past 6 months prior to the first study drug administration.
- •History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 12 months prior to screening.
- •Average intake of more than 24 units of alcohol per week: one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
- •Positive screen for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies, human immunodeficiency virus 1 and 2 antibodies, or syphilis at screening. Note: Hepatitis B vaccination is allowed.
研究组 & 干预措施
Part A
A single intravenous (IV) dose of BAL2420 or placebo will be administered to healthy subjects
干预措施: BAL2420 or placebo (Drug)
Part B
A daily IV dose of BAL2420 or placebo will be administered multiple times to healthy subjects
干预措施: BAL2420 or placebo (Drug)
Part C
A different IV dosing regimen of BAL2420 or placebo will be administered to healthy subjects
干预措施: BAL2420 or placebo (Drug)
结局指标
主要结局
Number of participants with abnormal electrocardiograms QT Interval in Part A
时间窗: From screening until Day 10
Number of participants with abnormal ECG QT Interval in Part B and C
时间窗: From screening until Day 14
Number of participants reporting adverse events (AEs) in Part A
时间窗: From screening until Day 10
Number of participants reporting adverse events (AEs) in Part B and C
时间窗: From screening until Day 14
次要结局
未报告次要终点