Clinical study to assess the safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with RSV infectio

Phase 1

• Conditions: Respiratory Syncytial Virus Infections; Respiratory syncytial virus as the cause of diseases classified to other chapters; C02.782.580.600.620.750; B97.4

• Registration Number: RBR-5497s9
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo - HCFMRP-USP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria: Participant has presented at the hospital for suspected Respiratory Syncytial Virus (RSV) infection within 72 hours prior to Screening completion; Participant has been hospitalized for this suspected RSV infection; Participant has been diagnosed with RSV infection using a polymerase chain reaction (PCR)-based assay, preferably commercially available locally; Participant was born after a normal term pregnancy (greater than or equal to 37 weeks and 0 days); A legally acceptable representative of the participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, are willing for their child to participate in the study, are willing for their child to remain in the hospital for the first 3 days of dosing (even if not clinically indicated), and are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures

Exclusion Criteria

Exclusion Criteria: Participant who had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study; Participant has major congenital anomalies or known cytogenetic disorders; Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection; Participant has known or suspected hepatitis B or C infection; Participant is upon current admission initially hospitalized in the Intensive care unit (ICU) and/or in need of invasive endotracheal mechanical ventilation

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of JNJ- 53718678 - The Cmax is the maximum observed plasma concentration.;