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drugset / Trial / NCT04068792

A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease

NCT04068792 ↗

Phase 2 Completed 22 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this two-part designed study is to assess in the setting of a planned early interception of pediatric RSV disease, early viral and disease kinetics (observational stage) and the antiviral effects of an Respiratory Syncytial Virus (RSV) fusion inhibitor, JNJ-53718678 (interventional stage). In the observational stage the infant is closely monitored for early symptoms by the parent(s)/caregiver(s) and thus may be brought in for diagnosis earlier than in the typical setting.

Timeline

Start
2019-10-10
Primary completion
2021-05-15
Completion
2021-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilematovir Other / unclassified 2.5 mg/kg —
Subject Rilematovir Other / unclassified 3 mg/kg —
Subject Rilematovir Other / unclassified 4.5 mg/kg —

Indications

respiratory syncytial virus infectious disease