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Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection

NCT03656510 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2025-02-04

Study results available
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Summary

The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants \[Cohort 1\] or outpatients \[Cohort 2\]).

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

DRUG

JNJ-53718678

Participants will receive JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.

DRUG

Placebo

Participants will receive matching placebo (high volume or low volume) orally twice daily for 7 days.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-29
Primary Completion
2022-04-18
Completion
2022-04-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03656510 on ClinicalTrials.gov