NCT03382431已完成1 期
A Single-blind, Placebo Controlled, Randomised Study to Evaluate Antiviral Activity and Safety and Pharmacokinetics of Inhaled PC786 Against Respiratory Syncytial Virus (RSV) in Healthy Adult Subjects in a Virus Challenge Model
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- RSV viral load
研究概览
简要总结
PC786 is a new medicine being developed for treatment of respiratory syncytial virus. The main purpose of this study is to evaluate the antiviral activity of PC786 in healthy adults infected with RSV virus in a viral challenge study.
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
- Single (Participant)
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
- •Subject is in good health as determined by the Investigator based on medical history, physical examination, and routine laboratory tests at a screening evaluation.
- •Male or female, aged between 18 and 55 years inclusive
- •Body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 30kg/m2
- •Subject must provide written informed consent
- •Serosuitable to the challenge virus.
排除标准
- •History or evidence of any clinically significant or currently active major clinical illness.
- •Any significant abnormality altering the anatomy of the nose or nasopharynx
- •Any nasal or sinus surgery within six months of the study
- •Abnormal lung function
- •Positive human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test.
- •Presence of cold like symptoms and/or fever on admission for the study
- •History or currently active symptoms suggestive of upper or lower respiratory tract infection within 6 weeks of the study
- •History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug
研究组 & 干预措施
PC786
Experimental
Repeat dose
干预措施: PC786 (Drug)
Placebo/vehicle
Placebo Comparator
Repeat dose
干预措施: Placebo/vehicle (Drug)
结局指标
主要结局
RSV viral load
时间窗: Baseline to Day 28
AUC 0-t for RSV viral load measured in nasal washes by reverse transcription quantitative polymerase chain reaction (RT-qPCR)
次要结局
- Number of participants reporting one or more treatment-emergent adverse event (TEAE)(Screening to Day 28)
- Number of participants who discontinue due to an adverse event(Screening to Day 28)
- Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose(Screening to Day 28)
- Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose(Screening to Day 28)
- Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose(Screening to Day 28)
- Number of participants who meet the markedly abnormal criteria for spirometry (FEV1 & FVC measured together) assessments at least once post dose(Screening to Day 28)
- Area under the plasma concentration versus time curve (AUC) of PC786 measured in plasma(Pre-dose and at multiple time points to Day 12)
- Maximum observed concentration (Cmax) of PC786 measured in plasma(Pre-dose and at multiple time points to Day 12)
- Apparent terminal half life (T1/2) of PC786 measured in plasma(Pre-dose and at multiple time points to Day 12)
- Determination of nasal concentrations of PC786(Pre-dose and at multiple time points to Day 28)
- Comparison of mucus production following treatment with PC786 or placebo post viral inoculation(Baseline to Day 12)
- Comparison of the effect of treatment with PC786 or placebo on RSV symptoms(Baseline to Day 12)
- Time maximum concentration observed (Tmax) of PC786 measured in plasma(Pre-dose and at multiple time points to Day 12)
- Change in viral load measured in nasal wash(Baseline to Day 12)
- Time to non-detectability of virus measured in nasal wash(Baseline to Day 12)
- Peak viral load measured in nasal wash(Baseline to Day 12)
- Time peak viral load observed measured in nasal wash(Baseline to Day 12)
研究者
研究点 (1)
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