A Single Part, Four-Way Crossover, Randomized, Partially-Blinded Study to Evaluate the Effect of Intravenous ANG-3777 on Baseline-Adjusted QT/QTc Interval in the Fasted State in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change from baseline in corrected QT interval by Fridericia's formula for ANG-3777 at the therapeutic and supra-therapeutic dose levels compared to placebo
研究概览
简要总结
The purpose of this study is to evaluate the effect of ANG-3777 on placebo-corrected change from baseline, QT/corrected QT (QTc) interval, following single intravenous (IV) doses in healthy volunteer adults.
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
Partially blinded study. Patients are blinded as to treatment assignment. Care Provider, Investigator, and Outcomes Assessor will be blinded to ANG-3777 IV or saline IV, but Moxifloxacin Hydrochloride pill will be provided open label.
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
- •Healthy males or non-pregnant, non-lactating healthy females
- •Aged 18 to 55 years inclusive at the time of signing informed consent
- •Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- •Weight ≥50 kg and ≤100 kg at screening and admission
- •Must be willing and able to comply with all study requirements
- •Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures
- •Must agree to use an adequate method of contraception
排除标准
- •Subjects who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event, shall the time between last receipt of IMP and first dose be less than 30 days.
- •Subjects who are study site or sponsor employees, or are immediate family members of a study site or sponsor employee
- •Evidence of current SARS-CoV-2 infection
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine)
- •A confirmed positive alcohol urine test at screening or admission
- •Current smokers and those who have smoked within the last 12 months or current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •A confirmed positive urine cotinine test at screening or admission.
- •Positive drugs of abuse test result
研究组 & 干预措施
ANG-3777 (Therapeutic Dose)
Administered IV as a single dose on two occasions for 30 minutes on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration.
干预措施: ANG-3777 (Therapeutic Dose) (Drug)
Normal Saline
The placebo will be administered as a single dose on separate occasions intravenously as 30-minute infusions on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration.
干预措施: Placebo (Drug)
Moxifloxacin Hydrochloride
The comparator will be administered as a single dose oral Moxifloxacin Hydrochloride tablet (open-label), with a total of 240 mL of water. There will be a minimum washout of 3 days between each study drug administration.
干预措施: Moxifloxacin Hydrochloride (Drug)
ANG-3777 (Supra-therapeutic Dose)
Administered IV as a single dose on two occasions for 30 minutes on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration.
干预措施: ANG-3777 (Supra-therapeutic Dose) (Drug)
结局指标
主要结局
Change from baseline in corrected QT interval by Fridericia's formula for ANG-3777 at the therapeutic and supra-therapeutic dose levels compared to placebo
时间窗: Day 1, Day 5, Day 9 and Day 13
次要结局
未报告次要终点