NCT07214571招募中2 期
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus Who Are at High Risk of Progression to Severe Disease
Shionogi85 个研究点 分布在 2 个国家目标入组 192 人开始时间: 2025年12月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 85
- 主要终点
- Change From Baseline in RSV Ribonucleic Acid (RNA) Load by Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) (Nasopharyngeal Swab) at Day 2
研究概览
简要总结
The main purpose of this study is to investigate the antiviral effect of S-337395 compared with placebo among nonhospitalized adult participants with high-risk factors for progression to severe RSV infection starting intervention within 72 hours of RSV symptom onset.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have new onset or worsening (if present chronically) of at least 1 of the following signs and/or symptoms consistent with a viral acute respiratory infection within 72 hours prior to randomization: fever, nasal congestion, nasal discharge, sore throat, cough, sputum production, shortness of breath, or wheezing.
- •Participants diagnosed with RSV infection preferably using a rapid polymerase chain reaction (PCR) or other molecular-based diagnostic assay.
- •Has at least 1 of the following risk factors for severe RSV disease:
- •≥ 75 years of age;
- •Chronic lung disease that is symptomatic and requiring chronic treatment; and
- •Chronic cardiovascular disease that is symptomatic and requiring chronic treatment.
- •With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening.
排除标准
- •Hospitalized or expected to be hospitalized within 24 hours of screening.
- •Is considered by the investigator to be immunocompromised, due to an underlying medical condition or medical therapy, chemotherapy, radiation, stem cell or solid organ transplant.
- •Has known allergies, hypersensitivity, or intolerance to S-337395 or to any of the excipients of the S-337395 or placebo formulation.
- •Suspicion or known severe renal impairment.
- •Any other medical or psychiatric condition making the participant unsuitable for the current study or interfering with the evaluation of response to the study intervention in the opinion of the investigator/subinvestigator.
- •Has received a therapy intended to treat RSV infection within 14 days prior to screening.
- •Is receiving chemotherapy or immunotherapy for malignancy.
- •Has received RSV vaccination within 7 days prior to screening.
- •Has had either confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza infection (test was positive) during the 28 days prior to screening.
- •Has any other confirmed clinically relevant respiratory infection by any pathogen at, or within 28 days of screening.
- •Note: Other protocol-specified inclusion and exclusion criteria may apply.
研究组 & 干预措施
S-337395 Low Dose
Experimental
Participants will receive a low dose of S-337395 BID orally for up to 5 days.
干预措施: S-337395 (Drug)
S-337395 High Dose
Experimental
Participants will receive a high dose of S-337395 twice daily (BID) orally for up to 5 days.
干预措施: S-337395 (Drug)
Placebo
Placebo Comparator
Participants will receive matching placebo BID orally for 5 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in RSV Ribonucleic Acid (RNA) Load by Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) (Nasopharyngeal Swab) at Day 2
时间窗: Baseline, Day 2
Change From Baseline in RSV RNA Load by qRT-PCR (Nasopharyngeal Swab) at Day 4
时间窗: Baseline, Day 4
Change From Baseline in RSV RNA Load by qRT-PCR (Nasopharyngeal Swab) at Day 6
时间窗: Baseline, Day 6
次要结局
- Percentage of Participants With RSV RNA Load <LLOQ(Baseline up to Day 6)
- Percentage of Participants With RSV Infectious Titer <LLOQ(Baseline up to Day 6)
- Percentage of Participants With Negative RSV RNA Load by qRT-PCR(Baseline up to Day 6)
- Time to the First RSV RNA Load <Lower Limit of Quantitation (LLOQ)(Baseline up to Day 6)
- Time to Sustained RSV RNA Load <LLOQ(Baseline up to Day 6)
- Change From Baseline in Infectious Titer(Baseline up to Day 6)
- AUC of Change From Baseline in Infectious Titer(Baseline up to Day 6)
- Time to the First Negative RSV Infectious Titer(Baseline up to Day 6)
- Time to Sustained Negative RSV Infectious Titer(Baseline up to Day 6)
- Percentage of Participants With Negative RSV Infectious Titer(Baseline up to Day 6)
- Time to the First RSV Infectious Titer <LLOQ(Baseline up to Day 6)
- Time to Sustained RSV Infectious Titer <LLOQ(Baseline up to Day 6)
- Change From Baseline in RSV RNA Load(Baseline up to Day 6)
- Area Under the Curve (AUC) of Change From Baseline in RSV RNA Load(Baseline up to Day 6)
- Time to the First Negative RSV RNA Load by qRT-PCR(Baseline up to Day 6)
- Time to Sustained Negative RSV RNA Load by qRT-PCR(Baseline up to Day 6)
- Time to First Resolution of All Respiratory and Systemic RSV-related Symptoms Based on the Combined RiiQ RSS and RiiQ-SSS(Baseline up to Day 6)
- Time to Sustained Resolution of All Respiratory and Systemic RSV-related Symptoms Based on the Combined RiiQ RSS and RiiQ-SSS(Baseline up to Day 6)
- Time to First Resolution of Each Separate RSV-related Symptom Based on the RiiQ Symptom Subscale(Baseline up to Day 6)
- Time to Sustained Resolution of Each Separate RSV-related Symptom Based on the RiiQ Symptom Subscale(Baseline up to Day 6)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Day 1 up to Day 28)
- Change From Baseline in Severity of RSV Respiratory Symptom Score Based on the Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Respiratory Symptom Subscale (RiiQ-RSS)(Baseline up to Day 6)
- Change From Baseline in Severity of RSV Systemic Symptoms Score Based on the RiiQ Systemic Symptom Subscale (RiiQ-SSS)(Baseline up to Day 6)
- Change From Baseline in Severity of RSV Total Symptoms Score Based on the Combined RiiQ RSS and RiiQ-SSS(Baseline up to Day 6)
- Time to First Resolution of All Respiratory RSV-related Symptoms Based on the RiiQ-RSS(Baseline up to Day 6)
- Time to Sustained (2 Consecutive Days) Resolution of All Respiratory RSV-related Symptoms Based on the RiiQ-RSS(Baseline up to Day 6)
- Time to First Resolution of All Systemic RSV-related Symptoms Based on the RiiQ-SSS(Baseline up to Day 6)
- Time to Sustained Resolution of All Systemic RSV-related Symptoms Based on the RiiQ-SSS(Baseline up to Day 6)
- Plasma Concentration of S-337395 After Repeated Oral Doses of S-337395(Baseline up to Day 6)
- Plasma Concentration of S-337395 12 and 24 Hours After the First Dose and the Last Dose (C12 and C24)(12 hours and 24 hours after first dose (Day 2) and last dose (Day 6))
研究者
研究点 (85)
Loading locations...
相似试验
已完成
2 期
A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus InfectionHepatitis B, ChronicNCT03982186Janssen Sciences Ireland UC471
已完成
3 期
Study of Lopinavir/ Ritonavir and Lamivudine Versus Standard Therapy in Naïve HIV-1 Infected Subjects.HIV InfectionNCT01237444Pedro Cahn417
已完成
1 期
Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C InfectionHepatitis CNCT00911963Vertex Pharmaceuticals Incorporated49
已完成
3 期
A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-LamivudineHIV InfectionsNCT00013897Bristol-Myers Squibb
已完成
3 期
Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected PatientsHIV InfectionNCT00234910Abbott152