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

A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection Due to RSV

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 28 Days – 4 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Syncytial Viruses

Interventions

Type	Name	Description
OTHER	RSV Mobile Application	Participants will not receive any intervention in observational phase of this study. Participant's respiratory symptoms will be captured by RSV mobile application installed in participant's caregiver/parent mobile phone.
DRUG	Placebo	Participants in each Age Group (1,2,3) will receive matching placebo (volume placebo to match the calculated volume of the JNJ-53718678 dose) orally twice daily for 7 days.
DRUG	JNJ-53718678 2.5 mg/kg	JNJ-53718678 will be administered to Age Group 1 twice daily for 7 days.
DRUG	JNJ-53718678 3 mg/kg	JNJ-53718678 will be administered to Age Group 2 twice daily for 7 days.
DRUG	JNJ-53718678 4.5 mg/kg	JNJ-53718678 will be administered to Age Group 3 twice daily for 7 days.

Timeline

• Start date: 2019-10-10
• Primary completion: 2021-05-15
• Completion: 2021-05-15
• First posted: 2019-08-28
• Last updated: 2025-02-04
• Results posted: 2022-06-08

Locations

10 sites across 5 countries: Argentina, Belgium, Panama, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study