Who is sponsoring NCT02593851?

NCT02593851 is sponsored by Janssen Sciences Ireland UC.

What drugs are being tested in NCT02593851?

Interventions in NCT02593851: JNJ-53718678, Placebo.

What condition does NCT02593851 study?

NCT02593851 studies Respiratory Syncytial Virus Infections, Virus Diseases.

Is NCT02593851 still recruiting?

NCT02593851 is currently terminated. Last updated 6 December 2019.

Last reviewed 2019-12-06 · How we verify

NCT02593851

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

Terminated Phase 1 Last updated 6 December 2019

What this trial tests

Phase 1 trial testing JNJ-53718678 in Respiratory Syncytial Virus Infections in 45 participants. Terminated before completion.

Timeline

4 December 2015

Primary endpoint
21 March 2017

10 November 2017

Quick facts

Lead sponsor	Janssen Sciences Ireland UC
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	45
Start date	4 December 2015
Primary completion	21 March 2017
Estimated completion	10 November 2017
Sites	39 locations across Netherlands, Belgium, Sweden, Germany, Philippines, Argentina, Australia, Spain

Drugs / interventions tested

JNJ-53718678 — full drug profile →
Placebo

Conditions studied

Respiratory Syncytial Virus Infections — all drugs for Respiratory Syncytial Virus Infections →
Virus Diseases — all drugs for Virus Diseases →

Sponsor

Janssen Sciences Ireland UC — full company profile →

Who can join

Adults 1 Month to 24 Months, any sex, with Respiratory Syncytial Virus Infections or Virus Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate pharmacokinetics, safety, tolerability, antiviral activity, and impact on the clinical course of Respiratory Syncytial Virus (RSV) infection after multiple oral doses of JNJ-53718678 at different doses and/or dosing regimens in infants (greater than \[\>\] 1 month to less than or equal to \[\<=\] 24 months of age) who are hospitalized with RSV infection.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Innovation and trends in the development and approval of antiviral medicines: 1987-2017 and beyond.
Chaudhuri S, Symons JA, Deval J. · · 2018 · cited 136× · PMID 29758235 · DOI 10.1016/j.antiviral.2018.05.005
Past, Present and Future Approaches to the Prevention and Treatment of Respiratory Syncytial Virus Infection in Children.
Simões EAF, Bont L, Manzoni P, Fauroux B, et al · · 2018 · cited 116× · PMID 29470837 · DOI 10.1007/s40121-018-0188-z
Respiratory syncytial virus: from pathogenesis to potential therapeutic strategies.
Shang Z, Tan S, Ma D. · · 2021 · cited 74× · PMID 34671221 · DOI 10.7150/ijbs.64762
Pharmacokinetics, Safety, and Antiviral Effects of Multiple Doses of the Respiratory Syncytial Virus (RSV) Fusion Protein Inhibitor, JNJ-53718678, in Infants Hospitalized With RSV Infection: A Randomized Phase 1b Study.
Martinón-Torres F, Rusch S, Huntjens D, Remmerie B, et al · · 2020 · cited 26× · PMID 32201897 · DOI 10.1093/cid/ciaa283
Monitoring Severity of Respiratory Syncytial Virus (RSV) in Infants and Young Children Using the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS): Results of Initial Quantitative Validation.
de la Loge C, Fofana F, Williams P, Rusch S, et al · · 2021 · cited 2× · PMID 34326675 · DOI 10.2147/prom.s298736

Verify or expand the search:

Other trials of JNJ-53718678

Trials testing the same drug.

NCT04332523 — A Study of JNJ-53718678 in Participants With Hepatic Impairment · Phase 1 · terminated
NCT04090086 — A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Particip · Phase 1 · completed
NCT03656510 — Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respi · Phase 2 · terminated
NCT03002779 — A Study to Characterize the Absorption, Metabolism, and Excretion of 14C-JNJ-53718678 After a Single Oral Dose in Health · Phase 1 · completed
NCT02945007 — A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-53718678 Administered as Oral Concept Formul · Phase 1 · completed

Other recruiting trials for Respiratory Syncytial Virus Infections

Currently open trials in the same condition.

NCT07214571 — A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of · Phase 2 · recruiting
NCT07220109 — A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 5 · Phase 3 · recruiting
NCT07239583 — Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus ) · recruiting
NCT07092865 — A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and th · Phase 2 · recruiting
NCT06684379 — Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm for the Treatment of A · Phase 1, PHASE2 · recruiting

Other Janssen Sciences Ireland UC trials

Trials by the same sponsor.

NCT04208399 — A Study to Evaluate the Effect of Hepatic Impairment on JNJ-56136379 · Phase 1 · completed
NCT04208386 — A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989 · Phase 1 · completed
NCT04056611 — Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who A · Phase 2 · terminated
NCT04129554 — A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virolo · Phase 2 · completed
NCT03982186 — A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepati · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02593851 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Sciences Ireland UC
Last refreshed: 6 December 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02593851.

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