NCT01313962已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled Assessment of the Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of Flufirvitide-3 Nasal Spray in Healthy Subjects
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
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and pharmacokinetic profile of flufirvitide-3 nasal spray in healthy subjects.
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
- Double (Participant, Investigator)
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
- •Provision of signed and dated, written informed consent prior to any study-specific procedures.
- •Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements.
- •Healthy male and non-fertile female subjects aged 18 and 55 years inclusive
- •Female subjects must have a negative urine pregnancy test at screening must not be lactating or breastfeeding and must be of non-childbearing potential
- •Male subjects should be willing to use barrier contraception during sexual intercourse,
- •Body weight 50 to 100 kg inclusive and body mass index (BMI) 18 to 30 kg/m2 inclusive.
- •Clinically non-significant findings on physical examination in relation to age.
- •Negative Rapid Flu Test (TRU FLU® kit)
- •Negative nasal examination upon admission to the study center.
排除标准
- •History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorders,
- •History and/or presence of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Subjects with a surgical history of the gastrointestinal tract should also be excluded from participation in the study.
- •Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of the investigational product which is symptomatic enough to affect study conduct or the well-being of the subject
- •History and/or presence of asthma or recurrent sinusitis. Active rhinitis at screening or upon admission to the study center.
- •Any clinically significant nasal septum deviation, presence of septum perforations, and history of recurrent epistaxis and nasal polyps.
- •Subjects with a history of sinus surgery and/or persistent hypertrophic inferior turbinates.
- •History of vaccination with live vaccine within 7 days or attenuated vaccine within 14 days of the administration of the investigational product.
- •Any clinically significant abnormalities in clinical laboratory safety assessment results
- •A positive result at screening on serum hepatitis B surface antigen, hepatitis C antibodies and HIV antibodies.
- •Significant orthostatic reaction at screening or upon admission to the study center as judged by the Principal Investigator.
- •Abnormal vital signs, after 5 minutes supine rest,
- •Any clinically significant abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (ECG) that may interfere with the interpretation of QTc interval changes.
- •Prolonged QTcF greater than 450 ms or shortened QTcF less than 360 ms or family history of long QT syndrome.
- •Known or suspected drugs of abuse or alcohol abuse or dependence
- •Positive screen for drugs of abuse or alcohol at screening or upon admission to the study center.
- •Excessive intake of caffeine-containing foods or beverages within 48 hours prior to the admission to the study center.
- •Use of drugs with enzyme-inducing properties such as St John's Wort, within 3 weeks prior to the administration of the investigational product.
- •Abstain from smoking from 30 days prior to screening and for the duration of the study.
- •Use of any prescribed medication as well as any over-the-counter/non prescribed/ herbal medicines, within 2 weeks prior to administration of the investigational product.
- •Use of any nasal steroid 3 months prior to the administration of the investigational product.
- •Involvement in the planning and/or conduct of the study
- •Have received another new chemical entity or has participated in any other clinical study that included drug treatment within 3 months prior to administration of the investigational product in this study.
- •Previous randomization of treatment in the present study or any other study with Flufirvitide-
- •Plasma donation within 4 weeks prior to enrollment or blood donation
研究组 & 干预措施
Flufirvitide-3
Experimental
干预措施: Flufirvitide-3, 0.4 mg single dose (Drug)
Flufirvitide-3
Experimental
干预措施: Flufirvitide-3 0.05 mg single dose (Drug)
Flufirvitide-3
Experimental
干预措施: Flufirvitide-3, 0.1 mg single dose (Drug)
Flufirvitide-3
Experimental
干预措施: Flufirvitide-3, 0.2 mg single dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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