A Randomised, Double-blind, Placebo-controlled, Parallel Group Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of IRL201104 to Support a Future COVID-19 Patient Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of subjects with PCI and/or abnormal electrocardiogram variables will be summarised by treatment
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects age 18 to 65 years of age, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
- •Female subjects agree to use highly effective contraception or be of non-childbearing potential.
- •Written informed consent must be obtained before any assessment is performed.
- •Able to communicate well with the Investigator/designee.
排除标准
- •Any known reaction to study drug or components
- •concurrent or recent infection or clinically significant conditions that may place subject at risk or interference with absorption, distribution or excretion of drugs
- •No QTcF interval ≥450 milliseconds, no QRS complex ≥120 milliseconds, at Screening
- •Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or -2 antibodies at Screening.
- •Excessive use of caffeine-containing beverages
- •Urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months before screening.
- •Presence or history of drug of alcohol abuse.
- •Positive screen for drugs-of-abuse or cotinine.
- •Blood donation in excess of 500mL within 3 months.
- •Participation in another clinical study with licensed or unlicensed study drug within 3 months of first IMP administration.
- •Exposure to more than 4 new chemical entities within 12 months before the first IMP administration.
- •Use of live vaccine 28 days before dosing with study drug until telephone follow-up and use of killed vaccine (including COVID-19 vaccine) 14 days before dosing with study drug until telephone follow-up.
研究组 & 干预措施
Group 1: Dose A IRL201104 or placebo
IRL201104 IV once daily for 5 days OR Placebo IV once daily for 5 days
干预措施: IRL201104 (Drug)
Group 1: Dose A IRL201104 or placebo
IRL201104 IV once daily for 5 days OR Placebo IV once daily for 5 days
干预措施: Placebo (Drug)
Group 2: Dose B IRL201104 or placebo
IRL201104 IV once daily for 7 days OR Placebo IV once daily for 7 days
干预措施: IRL201104 (Drug)
Group 2: Dose B IRL201104 or placebo
IRL201104 IV once daily for 7 days OR Placebo IV once daily for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with PCI and/or abnormal electrocardiogram variables will be summarised by treatment
时间窗: 19 (group 1) or 21 (group 2) days
RR, PR, QRS, QT-interval, QTcF and heart rate will be collected at baseline and after dose administration and repeated until Day 19 or 21.
Number of subjects with PCI abnormal vital sign variables will be summarised by treatment
时间窗: 19 (group 1) or 21 (group 2) days
Blood pressure, pulse rate, oral body temperature and respiration rate will be collected at baseline and after single and multiple dose administration and repeated until Day 19 or 21
Number of subjects with potentially clinically important (PCI) abnormal haematology variables will be summarised by treatment
时间窗: 19 (group 1) or 21 (group 2) days
Haemoglobin, haematocrit, MCV, MCH, MCHC, RBC, WBC and differentials will be collected at baseline and after dose administration and repeated until Day 19 or 21
Number of subjects with PCI abnormal clinical chemistry variables will be summarised by treatment
时间窗: 19 (group 1) or 21 (group 2) days
Creatinine, glucose, triglycerides, urea, uric acid, bilirubin, cholesterol, sodium, potassium, alkaline phosphatase, AST, ALT and GGT will be collected at baseline and after dose administration and repeated until Day 19 or 21
Number of subjects with TEAEs and number of events will be summarised by treatment
时间窗: 33 (group 1) or 35 (group 2) days
Adverse Events after treatment administration will be collected at baseline and repeated until study completion
次要结局
- PK of IRL201104: Apparent total body clearance from blood (CLss)(5 (group 1) or 7 (group 2) days)
- Pharmacokinetics of IRL201104: Trough blood concentration (Ctrough)(5 (group 1) or 7 (group 2) days)
- PK of IRL201104: Maximum (peak) blood concentration (Cmax)(5 (group 1) or 7 (group 2) days)
- PK of IRL201104: Area under the curve from time zero to last quantifiable concentration of IRL201104 (AUCt)(5 (group 1) or 7 (group 2) days)
- PK of IRL201104: Terminal half life (t1/2)(5 (group 1) or 7 (group 2) days)
- PK of IRL201104: steady state volume of distribution (Vz)(5 (group 1) or 7 (group 2) days)