NCT06067191已完成1 期
A RANDOMISED, PHASE 1B, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RV299 AGAINST RESPIRATORY SYNCYTIAL VIRUS IN THE VIRAL 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
- 发起方
- Pfizer
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) for RSV-A Memphis 37b Viral Load Determined by Quantitative Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR)
研究概览
简要总结
The purpose of the study is to learn about the safety, pharmacokinetics and antiviral activity of the study medicine (RV299) for the potential treatment of respiratory syncytial virus (RSV). RSV is a highly contagious virus that can lead to serious lung infections in patients with reduced ability to fight infection. Most vulnerable populations include babies, the elderly and patients that have received a bone marrow transplant.
详细描述
This study is seeking healthy participants who are:
Healthy adult male and female participants aged between 18 to 55 years, with a total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2 and who have been screened to be sero-suitable for infection with the RSV-A Memphis 37b virus challenge virus.
A total of 80 participants is planned: 40 participants on RV299 and 40 participants on placebo.
The study is divided into 3 phases:
- Screening phase: from Day -90 to Day-3 pre-human viral challenge (HVC).
- Inpatient phase: Participants will be resident in the quarantine unit for approximately 15 days (from Day -2 to Day 12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Total body weight >= 50 kg and body mass index (BMI) >=18 kg/m2 and <=35 kg/m2
- •in good health with no history, or current evidence of clinically significant medical condition of laboratory, ECG or vital sign abnormality
- •Sero suitable for challenge virus
排除标准
- •History of or currently active symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to first study visit
- •Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immunosuppression),metabolic, urological, renal, neurological, or psychiatric disease and/or other major disease
- •females who are breastfeeding or have been pregnant within 6 months prior to the study or have a positive pregnancy test
- •Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction
- •Any significant abnormality altering the anatomy of the nose in a substantial way
- •Any clinically significant history of epistaxis (large nosebleeds)
- •Any nasal or sinus surgery within 3 months of first study visit
- •Evidence of vaccinations within 4 weeks of Day 0
- •Receipt of blood or blood products, or loss of 550 mL or more blood within last 3 months
- •Receipt of 3 or more investigational drug within last 12 months
- •Prior inoculation with a virus from the same virus-family as the challenge
- •Prior participation in another HVC study with a respiratory virus in last 3 months
- •Use or anticipated use during the conduct of the study of protocol specified concomitant medications
- •Systemic antiviral administration within 4 weeks of viral challenge
- •Confirmed positive test for drugs of abuse
- •History or presence of alcohol addiction, or excessive use of alcohol
- •A forced expiratory volume in 1 second (FEV1) <80%
- •Positive HIV, hepatitis B virus, or hepatitis C virus test
- •Presence of fever upto 2 days prior to Day 0.
研究组 & 干预措施
Active
Experimental
spray-dried dispersion (SDD) for Oral Suspension
干预措施: RV299 (Drug)
Placebo
Placebo Comparator
spray-dried dispersion (SDD) for Oral Suspension
干预措施: Placebo (Drug)
结局指标
主要结局
Area Under the Curve (AUC) for RSV-A Memphis 37b Viral Load Determined by Quantitative Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR)
时间窗: From initial administration of IMP up to the morning of quarantine discharge (up to Day 12)
Area under the curve (AUC) for RSV viral load measured in nasal washes by qRT-PCR in participants inoculated with RSV-A Memphis 37b, from initial administration of IMP up to the morning of Day 12 (Quarantine discharge) was presented in this outcome measure.
次要结局
- Peak Viral Load of RSV Determined by qRT-PCR(From initial administration of IMP up to planned discharge from quarantine (Up to Day 12))
- Time to Confirmed Negative Test by qRT-PCR Measurement Starting From Initial Administration of Investigational Medicinal Product (IMP) to First Confirmed Undetectable Assessment After Peak Measure(From first administration of IMP to the first confirmed negative qRT-PCR test or censoring date (up to Day 12))
- Time to Confirmed Negative Test by qRT-PCR Measurement Starting From Peak qRT-PCR After Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure(From peak qRT-PCR measurement to the first confirmed negative qRT-PCR test or censoring date (up to Day 12))
- Time to Peak qRT-PCR Starting From Initial Administration of IMP(From first administration of IMP to peak qRT-PCR measurement (up to Day 12))
- Area Under the Viral Load-Time Curve (VL-AUC) for RSV-A Memphis 37b Determined by Viral Culture(From initial administration of IMP up to planned discharge from quarantine (up to Day 12))
- Peak Viral Load of RSV Determined by Viral Culture(From initial administration of IMP up to planned discharge from quarantine (up to Day 12))
- Time to Confirmed Negative Test by Viral Culture Measurement Starting From at Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure(From initial administration of IMP up to first confirmed undetectable assessment or censoring date (up to Day 12))
- Time to Symptom Resolution Starting at Peak Symptoms After Initial Administration to 24 Hours Symptom Free(From time of highest total symptom score until time of symptom resolution or censoring date (up to Day 12))
- Time to Confirmed Negative Test by Viral Culture Measurement Starting From Peak Viral Culture After Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure(From peak qRT-PCR measurement to first confirmed undetectable assessment or censoring date (up to Day 12))
- Area Under the Curve Over Time of Total Clinical Symptoms as Measured From 10 Symptoms Within the Graded Symptom Scoring System(From initial administration of IMP (before or after administration) up to planned discharge from quarantine (up to Day 12))
- Area Under the Curve Over Time of Total Clinical Symptoms Change From Baseline (TSS-AUC-CFB) as Measured From 10 Symptoms Within the Graded Symptom Scoring System(Baseline (assessment nearest to the time of the first administration of IMP) up to Day 12)
- Overall Peak Total Clinical Symptoms (TSS) Score(From initial administration of IMP (before or after administration) up to planned discharge from quarantine (up to Day 12))
- Individual Maximum Daily Peak Symptom Score(Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9 (days relative to first administration of IMP))
- Time to Symptom Resolution Starting at Initial Administration of IMP to 24 Hours Symptom Free(From first administration of IMP until time of symptom resolution or censoring date (up to Day 12))
- Time to Peak Symptom Score From Initial Administration of IMP(From first dose of IMP until time of highest total symptom score or censoring date (Up to Day 12))
- Total Weight of Mucus Produced Starting at Initial Administration of IMP up to Planned Discharge From Quarantine(From first administration of IMP up to planned discharge from quarantine (up to Day 12))
- Total Number of Tissues Used by Participants Starting At Initial Administration of IMP up to Planned Discharge From Quarantine(From first administration of IMP up to planned discharge from quarantine (up to Day 12))
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From first dose of IMP until end of follow-up visit (up to Day 28))
- Number of Participants With AEs Related to Viral Challenge(From viral challenge on Day 0 up to end of follow-up (Day 28))
- Number of Participants With Concomitant Medications(From viral challenge on Day 0 up to end of follow-up (Day 28))
- Time to Maximum Plasma Concentration (Tmax) for RV299(Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96-hours post-dose 1 and dose 10)
- Terminal Half-Life (t1/2) for RV299(Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 and dose 10)
- Maximum Observed Plasma Concentration for RV299(Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 and dose 10)
- Area Under the Plasma Concentration-Time Curve From Time Zero to the End of the Dosing Interval for RV299(Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12 hours post-dose 1 and dose 10)
- Area Under the Plasma Concentration-Time Curve Over the Last 24 Hours Dosing Interval for RV299(Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24 hours post-dose 1 and dose 10)
- Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity for RV299 on Day 1(Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1)
研究者
研究点 (1)
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