A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Effect of Ha44 Gel on the ECG in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF
研究概览
简要总结
The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers.
详细描述
This study was a randomized, double-blind, placebo- and active-controlled, crossover study that evaluated the potential of Abametapir to prolong cardiac repolarization in healthy adult subjects (total of 57 subjects).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-dummy technique was used to mask the treatments. The test product is a gel and the positive control is a tablet. The active test product was administered with placebo positive control, while the active positive control was administered with placebo test product. The placebo group received both placebos.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy male or female subject, 18 to 50 years of age, inclusive, at least 45 kg and has a body mass index (BMI) of 18 to 33 kg/m2,
- •Female subjects of childbearing potential must not be pregnant and not lactating or prepared to practice highly effective birth control methods
- •The subject has normal 12-lead ECG results or, if abnormal, the abnormality is not clinically significant (as determined by the investigator).
排除标准
- •has evidence of cardiac conduction abnormalities
- •history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative due to cardiac causes at a young age
- •potassium, calcium, or magnesium levels that are below the clinical laboratory's lower limit of normal
- •laboratory test results at Screening are >2 x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), >1.5 x ULN for bilirubin, or >1.5 x ULN for creatinine
- •history or evidence of any clinically significant (as determined by the investigator) cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
- •febrile illness or symptomatic viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week before clinic admission
- •supine mean systolic blood pressure <90 or >140 mmHg and a mean diastolic blood pressure <50 or >90 mmHg
- •positive for HIV or hepatitis C antibody or hepatitis B antigen (HBsAg)
研究组 & 干预措施
HA44 Abametapir Lotion
Study drug plus positive-control placebo.
干预措施: Ha44 (Drug)
HA44 Abametapir Lotion
Study drug plus positive-control placebo.
干预措施: Moxifloxacin Placebo (Drug)
Placebo
Placebo plus positive-control placebo.
干预措施: Ha44 Placebo (Drug)
Placebo
Placebo plus positive-control placebo.
干预措施: Moxifloxacin Placebo (Drug)
Moxifloxacin
Placebo plus positive control
干预措施: Ha44 Placebo (Drug)
Moxifloxacin
Placebo plus positive control
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF
时间窗: 36 hours
The primary endpoint is the difference between the active (HA44) and placebo for time matched baseline adjusted mean QTcF = \[ΔQTcF (Ha44 0.74% Gel) - ΔQTcF (placebo)\] = ΔΔQTcF. This was compared with the difference between Moxifloxacin and placebo for time matched baseline adjusted mean QTcF = \[ΔQTcF (Moxifloxacin) - ΔQTcF (placebo)\] = ΔΔQTcF
次要结局
未报告次要终点