- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02387606
Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.
October 25, 2022 updated by: Janssen Sciences Ireland UC
A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
66
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
Participants will receive placebo or JNJ-53718678 500 milligram (mg) or 200 mg once daily for 7 days.
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Participants will receive placebo once daily.
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.
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Experimental: Cohort 2
Participants will receive placebo or JNJ-53718678; dosing regimen in Cohort 2 will be decided based on Cohort 1 results.
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Participants will receive placebo once daily.
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.
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Experimental: Cohort 3
Participants will receive placebo or JNJ-53718678, 75 mg once daily for 7 days.
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Participants will receive placebo once daily.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Viral Load-time Curve (VL AUC)
Time Frame: up to Follow-up (Day 28)
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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.
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up to Follow-up (Day 28)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Viral Load-time Curve (VL AUC) Determined by Plaque Forming Unit (PFU) Assay
Time Frame: Baseline up to Follow-up (Day 28)
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VL AUC for RSV-A Memphis 37b will be determined by PFU assay of nasal wash.
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Baseline up to Follow-up (Day 28)
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Viral Load Over Time
Time Frame: Baseline up to Follow-up (Day 28)
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Baseline up to Follow-up (Day 28)
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Peak Viral Load
Time Frame: Baseline up to Follow-up (Day 28)
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Baseline up to Follow-up (Day 28)
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Time To Peak Viral Load
Time Frame: Baseline up to Follow-up (Day 28)
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Time to peak viral load will be reported.
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Baseline up to Follow-up (Day 28)
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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
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24 hours after first dose
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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
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48 hours after first dose
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Time to Non-detectability of Virus
Time Frame: Baseline up to Follow-up (Day 28)
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Time to non-detectability of virus from first administration of study drug will be assessed.
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Baseline up to Follow-up (Day 28)
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Total Clinical Symptom Score
Time Frame: Admission (Day -1 or -2) up to Day 13
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Total clinical symptom score will be assessed using a composite of 10 self-reported symptoms on the Symptom Diary Card.
The Investigator will review the participant's SDC entries on a daily basis after the administration of challenge virus inoculum.
Total Clinical Symptom Score ranges from 0 (no symptoms) to 3 (not well).
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Admission (Day -1 or -2) up to Day 13
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Time to Peak Symptom Score After Viral Inoculation
Time Frame: Admission (Day -1 or -2) up to Day 13
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Admission (Day -1 or -2) up to Day 13
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Mucus Weight
Time Frame: Baseline up to Day 13
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Baseline up to Day 13
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Tissue Count
Time Frame: Baseline up to Day 13
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Baseline up to Day 13
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Sequence Analysis of the Rsv-A Memphis 37b Genome
Time Frame: Baseline and post-Baseline
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Baseline and post-Baseline
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Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry
Time Frame: Baseline up to Follow-up (Day 28)
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FEV1 is the amount of air that can be exhaled in one second.
FEV1 will be measured by spirometry.
A positive change from baseline in FEV1 indicates improvement in lung function.
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Baseline up to Follow-up (Day 28)
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Forced Vital Capacity (FVC) Measured by Spirometry
Time Frame: Baseline up to Follow-up (Day 28)
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FVC is the total volume of air expired after a full inspiration.
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Baseline up to Follow-up (Day 28)
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FEV1/FVC Ratio
Time Frame: Baseline up to Follow-up (Day 28)
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Baseline up to Follow-up (Day 28)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2015
Primary Completion (Actual)
September 21, 2015
Study Completion (Actual)
October 2, 2015
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
March 9, 2015
First Posted (Estimate)
March 13, 2015
Study Record Updates
Last Update Posted (Actual)
October 26, 2022
Last Update Submitted That Met QC Criteria
October 25, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR106786
- 2014-005041-41 (EudraCT Number)
- 53718678RSV2001 (Other Identifier: Janssen Sciences Ireland UC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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