Completed
PHASE2
INTERVENTIONAL
NCT03379675
A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Detailed Description
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.
Interventions
Name:
JNJ-53718678 500 mg
Type:
DRUG
Description:
Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.
Name:
JNJ-53718678 80 mg
Type:
DRUG
Description:
Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Name:
Placebo
Type:
DRUG
Description:
In treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Primary Outcomes
Measure:
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
TimeFrame:
Baseline through Day 3
Description:
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.
Measure:
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5
TimeFrame:
Baseline through Day 5
Description:
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Measure:
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8
TimeFrame:
Baseline through Day 8
Description:
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Measure:
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14
TimeFrame:
Baseline through Day 14
Description:
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Measure:
Change From Baseline in RSV Viral Load at Day 3
TimeFrame:
Baseline to Day 3
Description:
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.
Measure:
Change From Baseline in RSV Viral Load at Day 5
TimeFrame:
Baseline to Day 5
Description:
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.
Measure:
Change From Baseline in RSV Viral Load at Day 8
TimeFrame:
Baseline to Day 8
Description:
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.
Measure:
Change From Baseline in RSV Viral Load at Day 14
TimeFrame:
Baseline to Day 14
Description:
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.
Measure:
Change From Baseline in RSV Viral Load at Day 21
TimeFrame:
Baseline to Day 21
Description:
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.
Measure:
RSV Viral Load at Baseline
TimeFrame:
Baseline
Description:
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measure:
RSV Viral Load at Day 3
TimeFrame:
Day 3
Description:
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measure:
RSV Viral Load at Day 5
TimeFrame:
Day 5
Description:
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measure:
RSV Viral Load at Day 8
TimeFrame:
Day 8
Description:
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measure:
RSV Viral Load at Day 14
TimeFrame:
Day 14
Description:
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measure:
RSV Viral Load at Day 21
TimeFrame:
Day 21
Description:
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measure:
Time to Undetectable RSV Viral Load
TimeFrame:
Up to Day 21
Description:
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.
Measure:
Percentage of Participants With Undetectable RSV Viral Load at Day 3
TimeFrame:
Day 3
Description:
Percentage of participants with undetectable RSV viral load at Day 3 were reported.
Measure:
Percentage of Participants With Undetectable RSV Viral Load at Day 5
TimeFrame:
Day 5
Description:
Percentage of participants with undetectable RSV viral load at Day 5 were reported.
Measure:
Percentage of Participants With Undetectable RSV Viral Load at Day 8
TimeFrame:
Day 8
Description:
Percentage of participants with undetectable RSV viral load at Day 8 were reported.
Measure:
Percentage of Participants With Undetectable RSV Viral Load at Day 14
TimeFrame:
Day 14
Description:
Percentage of participants with undetectable RSV viral load at Day 14 were reported.
Measure:
Percentage of Participants With Undetectable RSV Viral Load at Day 21
TimeFrame:
Day 21
Description:
Percentage of participants with undetectable RSV viral load at Day 21 were reported.
Trial Information
NCT ID
NCT03379675
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Janssen Research & Development, LLC
Last Updated
December 15, 2025