CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
JNJ-53718678 500 mg +2 moredrug
Likely dose
JNJ-53718678 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03379675
NCT03379675Phase 2Completed
CompareCT.gov

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

Janssen Research & Development, LLC·interventional·Posted Dec 20, 2017·Updated Feb 4, 2025

In Brief

A Phase 2 clinical trial evaluating JNJ-53718678 500 mg, JNJ-53718678 80 mg, and 1 other intervention for Respiratory Syncytial Virus Infections. Completed, enrolled 72 participants across 124 sites in 19 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, France, Germany, Japan, Mexico, Poland, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 20, 2017
Enrollment StartFeb 6, 2018
Primary CompletionNov 27, 2019
Study CompletionDec 26, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.5 years ago

Interventions

JNJ-53718678 500 mgdrug

Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.

JNJ-53718678 80 mgdrug

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.

Placebodrug

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.