Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.

Janssen Sciences Ireland UC66 enrolled

Overview

The purpose of this study is to evaluate the antiviral effect of repeated oral dosing of JNJ 53718678 compared to placebo in healthy adult participants infected through inoculation with respiratory syncytial virus (RSV)-A Memphis 37b virus.

This is a randomized (study medication assigned to participants by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled, single-center study of JNJ 53718678 in healthy adult participants. Study consists of 3 phases: Screening (Day -56 and Study Day -3 prior to the planned date of virus inoculation/challenge on Study Day 0), quarantine (includes challenge on Day -1 or -2 and treatment for 7 days), and follow-up (Day 15 and 28). Participants will be admitted to the quarantine unit on Study Day -1 or - 2 and will be inoculated (intranasal) with the RSV-A Memphis 37b virus on Study Day 0. Participants will be evaluated in 3 cohorts: Cohort 1 and Cohort 3 (participants will be dosed with JNJ-53718678 or placebo for 7 days) and Cohort 2 (for up to 7 days \[Dosing Days 1-x\] \[x will be determined based on the results from Cohort 1\]). Participants will be randomized and JNJ-53718678/placebo dosing will be started after RSV presence in nasal wash has been detected by polymerase chain reaction (PCR). After completion of Cohort 1, data will be reviewed (unblinded) and the antiviral activity, safety, pharmacokinetic, clinical symptom and mucus weight data will be evaluated, based on which Cohort 2 will be initiated. Participants' safety will be monitored throughout the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Respiratory Syncytial Virus Infections

Interventions

PlaceboDRUG

Participants will receive placebo once daily.

JNJ-53718678DRUG

Participants will receive JNJ-53718678 as 20 milliliter (mL) (200 mg) or 50 mL (500 mg) oral solution (containing 10 mg JNJ-53718678 per mL) in Cohort 1. JNJ-53718678 dose in Cohort 2 will be decided based on Cohort 1 results. JNJ-53718678 as 7.5 mL (75 mg) oral solution (containing 10 mg JNJ-53718678 per mL) in Cohort 3.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female participants must be of non-childbearing potential: postmenopausal for at least 2 years or surgically sterile or otherwise incapable of becoming pregnant * Female participants, except for postmenopausal women, must have a negative serum pregnancy test at screening * Participants must agree to comply with contraceptive measures as mentioned in protocol * Participants must be sero-suitable for respiratory syncytial virus (RSV) within 57 days prior to inoculation * Participants must be non-smokers for at least one month prior to screening and participants must have a negative cotinine test at screening Exclusion Criteria: * Participants with a past history of heart arrhythmias (extrasystoli, tachycardia at rest) or of risk factors for Torsade de Pointes syndrome * Participants with a history or evidence of abuse of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 3 months, which in the Investigator's opinion would compromise participant's safety and/or compliance with the study procedures * Participants with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at screening * Participants with current hepatitis A infection, or hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at screening * Participants with active acute respiratory infection at admission (Study Day -1 or -2)

Locations (1)

Unnamed facility

London, United Kingdom

Outcomes

Primary Outcomes

Area Under the Viral Load-time Curve (VL AUC)

VL AUC for RSV-A Memphis 37b will be determined by quantitative reverse transcriptase -polymerase chain reaction (qRT-PCR) assay of nasal wash. The VL AUC will be calculated based on the viral load values measured 2 times per day, starting with the last value prior to first dosing, and ending with the last available value before discharge.

Time frame: up to Follow-up (Day 28)

Secondary Outcomes

Area Under the Viral Load-time Curve (VL AUC) Determined by Plaque Forming Unit (PFU) Assay

VL AUC for RSV-A Memphis 37b will be determined by PFU assay of nasal wash.

Time frame: Baseline up to Follow-up (Day 28)

Viral Load Over Time

Time frame: Baseline up to Follow-up (Day 28)

Peak Viral Load

Time frame: Baseline up to Follow-up (Day 28)

Time To Peak Viral Load

Time to peak viral load will be reported.

Time frame: Baseline up to Follow-up (Day 28)

Area Under the Viral Load-time Curve (VL AUC) From Time 0 to 24 Hours after First Dose

Time frame: 24 hours after first dose

Area Under the Viral Load-time Curve (VL AUC) From Time 0 to 48 Hours after First Dose

Time frame: 48 hours after first dose

Time to Non-detectability of Virus

Time to non-detectability of virus from first administration of study drug will be assessed.

Time frame: Baseline up to Follow-up (Day 28)

Data from ClinicalTrials.gov

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