A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 124
- 主要终点
- Change From Baseline in RSV Viral Load at Day 14
研究概览
简要总结
The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.
详细描述
This study will be performed to explore the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetics of JNJ-53718678 in adult participants infected with RSV. The study will include both participants who are otherwise healthy (ie, without underlying condition) or who have comorbid conditions (eg, asthma, chronic obstructive pulmonary disease (COPD), cardiovascular disease, other chronic diseases), with the exception of immunocompromised participants, presenting for medical care but not requiring hospitalization. The study will include a screening period (Day -1 to Day 1), a treatment Period (Day 1 to Day 8), and a follow-up period (Day 9 to Day 28). Safety evaluations will include adverse events, laboratory tests, electrocardiogram, vital signs, physical examination, and specific toxicities.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have an acute respiratory illness with signs and symptoms consistent with a viral infection (example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to 5 days from the anticipated time of randomization. Onset of symptoms is defined as the time the participant becomes aware of the first sign and/or symptom consistent with a viral infection
- •Participant has been diagnosed with respiratory syncytial virus (RSV) infection using a rapid polymerase chain reaction (PCR) based or rapid-antigen-detection test
- •Before randomization, a woman must be not of childbearing potential defined as: Premenarchal, Postmenopausal or Permanently sterile
- •A male participant must agree to the use of acceptable contraceptive measures
- •With the exception of the RSV-related illness the participant must be medically stable on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG) performed at screening
排除标准
- •Hospitalized participants or participants expected to be hospitalized within 24 hours of screening
- •History of or concurrent illness (beyond a comorbid condition) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit, or confound the protocol-specified assessments
- •Participants who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study
- •Participants who are considered by the investigator to be immunocompromised within the past 12 months
- •Participant has known or suspected chronic or acute hepatitis B or C infection
- •Women who are pregnant or breastfeeding
- •Participants with clinically significant abnormal ECG findings (other than QT-interval corrected for heart rate according to Fridericia [QTcF] interval greater than [>] 500 millisecond [ms]) not consistent with the underlying condition in the study population, as judged by the investigator
研究组 & 干预措施
Treatment A: JNJ-53718678 500 mg
Participants will receive 500 mg dose of JNJ-53718678 once daily for 7 days.
干预措施: JNJ-53718678 500 mg (Drug)
Treatment B: JNJ-53718678 80 mg + Placebo
Participants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
干预措施: JNJ-53718678 80 mg (Drug)
Treatment B: JNJ-53718678 80 mg + Placebo
Participants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
干预措施: Placebo (Drug)
Treatment C: Placebo
Participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in RSV Viral Load at Day 14
时间窗: Baseline to Day 14
Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3
时间窗: Baseline through Day 3
Area under the RSV VL-time curve (AUC) was determined as log10 copies\*hour per milliliter (Log10 copies\*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs.
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5
时间窗: Baseline through Day 5
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8
时间窗: Baseline through Day 8
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14
时间窗: Baseline through Day 14
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Change From Baseline in RSV Viral Load at Day 3
时间窗: Baseline to Day 3
Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Change From Baseline in RSV Viral Load at Day 5
时间窗: Baseline to Day 5
Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Change From Baseline in RSV Viral Load at Day 8
时间窗: Baseline to Day 8
Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Change From Baseline in RSV Viral Load at Day 21
时间窗: Baseline to Day 21
Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV Viral Load at Baseline
时间窗: Baseline
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV Viral Load at Day 3
时间窗: Day 3
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV Viral Load at Day 5
时间窗: Day 5
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV Viral Load at Day 8
时间窗: Day 8
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV Viral Load at Day 14
时间窗: Day 14
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV Viral Load at Day 21
时间窗: Day 21
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time to Undetectable RSV Viral Load
时间窗: Up to Day 21
The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.
Percentage of Participants With Undetectable RSV Viral Load at Day 3
时间窗: Day 3
Percentage of participants with undetectable RSV viral load at Day 3 were reported.
Percentage of Participants With Undetectable RSV Viral Load at Day 5
时间窗: Day 5
Percentage of participants with undetectable RSV viral load at Day 5 were reported.
Percentage of Participants With Undetectable RSV Viral Load at Day 8
时间窗: Day 8
Percentage of participants with undetectable RSV viral load at Day 8 were reported.
Percentage of Participants With Undetectable RSV Viral Load at Day 14
时间窗: Day 14
Percentage of participants with undetectable RSV viral load at Day 14 were reported.
Percentage of Participants With Undetectable RSV Viral Load at Day 21
时间窗: Day 21
Percentage of participants with undetectable RSV viral load at Day 21 were reported.
次要结局
- Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability(Up to Day 28)
- Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities(Up to Day 28)
- Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities(Up to Day 28)
- Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities(Up to Day 28)
- Peripheral Capillary Oxygen Saturation (SpO2) Over Time(Baseline, Days 3, 8, 14, and 21)
- Change From Baseline in Peripheral Capillary Oxygen Saturation(Baseline to Days 3, 8, 14 and 21)
- Pulse Rate Over Time(Baseline, Days 3, 8, 14 and 21)
- Change From Baseline in Pulse Rate(Baseline to Days 3, 8, 14 and 21)
- Respiratory Rate Over Time(Baseline, Days 3, 8, 14 and 21)
- Change From Baseline in Respiratory Rate(Baseline to Days 3, 8, 14 and 21)
- Body Temperature Over Time(Baseline, Days 3, 8, 14 and 21)
- Change From Baseline in Body Temperature(Baseline to Days 3, 5, 8, 14 and 21)
- Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose(0 to 24 hours post dose on Days 1 and 7)
- Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire(Baseline, Days 3, 5, 8, 14 and 21)
- Duration of Signs and Symptoms of RSV Assessed by RI-PRO(Baseline up to Day 21)
- Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire(Up to Day 21)
- Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire(Up to Day 21)
- Predose Plasma Concentration (Ctrough) of JNJ-53718678(Predose on Days 1 and 7)
- Maximum Plasma Concentration (Cmax) of JNJ-53718678(Days 1 and 7)