A Phase 1 interventional study of JNJ-53718678 and Placebo in Respiratory Syncytial Virus Infections and Virus Diseases, sponsored by Janssen Sciences Ireland UC. Terminated at 39 sites in 10 countries. Open to participants aged 1 Month to 24 Months. Per ClinicalTrials.gov, last updated 2019-12-06.
Sponsored by Janssen Sciences Ireland UC (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
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.
This is a Phase 1b, randomized (study medication assigned to participants by chance), partially double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled, multicenter, multiple ascending dose study of JNJ 53718678 in infants (greater than [>] 1 month to less than or equal to [\<=] 24 months of age) who are hospitalized with RSV infection. The duration of study will be approximately 4 weeks for each participant excluding screening period. In Part 1 of study, minimum total number of 42 participants will be divided in 3 cohorts: Age group 1 (Cohorts 1a-1e) (greater than or equal to [>=] 6 months and less than or equal to [\<=] 24 months of age), Age group 2 (Cohorts 2a-2e)(>=3 months and less than [\<] 6 months of age) and Age group 3 (Cohorts 3a-3e) (greater than [>] 1 month and \<3 months of age). Each age group will consist of a minimum of 3 cohorts with the possibility to add 2 more per age group (Cohorts a through e) in which different doses and/or dosing regimens will be evaluated. Each cohort will consist of 5 participants (4 participants receiving JNJ-53718678 and 1 participant receiving placebo for 7 days), except for the first cohort of each age group which will contain only 4 participants (4 participants receiving JNJ 53718678). In Part 2 of the study, all age groups will be included in a single cohort, Cohort f, in which the selected dose regimen determined during Part 1 of the study will be used for each of the 3 age groups. A minimum of approximately 18 (12 participants receiving JNJ 53718678 and 6 participants receiving placebo) and a maximum of 24 participants (16 participants receiving JNJ 53718678 and 8 participants receiving placebo) will be included in this part of the study. Pharmacokinetics and safety of JNJ-53718678 will be evaluated primarily. Participants' safety will be monitored throughout the study.
302 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 48 are open to participants now.
This study's enrollment of 45 is below the median of 89 across 219 interventional studies indexed under Respiratory Syncytial Virus Infections.
Browse Respiratory Syncytial Virus Infections studies →Janssen Sciences Ireland UC is the lead sponsor of 29 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
Participants (greater than or equal to \[\>=\] 6 months and less than or equal to \[\<=\] 24 months of age) will receive JNJ-53718678, 2 milligram per kilogram body weight (mg/kg) oral solution once daily on Day 1 to Day 7. Dose and/or dosing regimen may be adapted in subsequent cohorts based on the review of the safety/tolerability and full pharmacokinetic data from Cohort 1a.
Drug: JNJ-53718678
Participants (\>= 6 months and \<= 24 months of age) will receive total daily dose of 6 mg/kg JNJ-53718678 oral solution or placebo \[either in once daily \[qd\] or twice daily \[bid\]) on Day 1 to Day 7.
Drug: JNJ-53718678 · Drug: Placebo
Participants (\>= 6 months and \<= 24 months of age) will receive total daily dose of 18 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7.
Drug: JNJ-53718678 · Drug: Placebo
Participants (\>= 6 months and \<= 24 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 1d is optional and may be included at the discretion of the sponsor.
Drug: JNJ-53718678 · Drug: Placebo
Participants (\>= 6 months and \<= 24 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 1e is optional and may be included at the discretion of the sponsor.
Drug: JNJ-53718678 · Drug: Placebo
Participants (\>= 3 months and less than \[\<\] 6 months of age) will receive total daily dose of 1.5 mg/kg JNJ-53718678 oral solution \[either in a qd or a bid regimen\] on Day 1 to Day 7.
Drug: JNJ-53718678
Participants (\>=3 months and \< 6 months of age) will receive total daily dose of 4.5 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7.
Drug: JNJ-53718678 · Drug: Placebo
Participants (\>= 3 months and \< 6 months of age) will receive total daily dose of 13.5 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7
Drug: JNJ-53718678 · Drug: Placebo
Participants (\>= 3 months and \< 6 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 2d is optional and may be included at the discretion of the sponsor.
Drug: JNJ-53718678 · Drug: Placebo
Participants (\>= 3 months and \< 6 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 2e is optional and may be included at the discretion of the sponsor.
Drug: JNJ-53718678 · Drug: Placebo
Participants (greater than (\>) 1 month and \< 3 months of age) will receive total daily dose of 1 mg/kg JNJ-53718678 oral solution \[either in a qd or a bid regimen\] on Day 1 to Day 7.
Drug: JNJ-53718678
Participants (\> 1 month and \< 3 months of age) will receive total daily dose of 3 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7.
Drug: JNJ-53718678 · Drug: Placebo
Participants (\> 1 month and \< 3 months of age) will receive total daily dose of 9 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7.
Drug: JNJ-53718678 · Drug: Placebo
Participants (\> 1 month and \< 3 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 3d is optional and may be included at the discretion of the sponsor.
Drug: JNJ-53718678 · Drug: Placebo
Participants (\> 1 month and \< 3 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 3e is optional and may be included at the discretion of the sponsor.
Drug: JNJ-53718678 · Drug: Placebo
Participants of all age groups will receive daily dose of JNJ-53718678 oral solution or placebo, either in a qd or a bid regimen on Days 1 to 7.
Drug: JNJ-53718678 · Drug: Placebo
JNJ-53718678 oral solution will be administered once or twice daily for 7 days.
Placebo oral solution will be administered once or twice daily for 7 days.
Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678
The Cmax is the maximum observed plasma concentration.
Time frame: Days 1, 2 and 3
Trough Plasma Concentration (Ctrough) of JNJ-53718678
The Ctrough is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
Time frame: Days 1, 2 and 3
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval.
Time frame: Days 1, 2 and 3
Total Apparent Clearance (CL/F) of JNJ-53718678
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: Days 1, 2 and 3
Apparent Volume of Distribution (Vd/F) of JNJ-53718678
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vd/F) is influenced by the fraction absorbed.
Time frame: Days 1, 2 and 3
Number of Participants With Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to Follow-up (Day 28)
Area Under the Viral Load-time Curve (VL AUC)
VL will be determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs. The VL AUC (copies. hour/ml) will be calculated based on the trapezoidal method.
Time frame: Up to Follow-up (Day 28)
Amount of Viral Load Over Time
VL (copies/ml) at each assessment timepoint where a nasal sample is obtained.
Time frame: Up to Follow-up (Day 28)
Number of viral particles at Peak Viral Load
Peak viral load (copies/ml) is a measure of the maximum number of viral particles present in nasal swabs.
Time frame: Up to Follow-up (Day 28)
Time To Peak Viral Load
Time (hours) to peak viral load will be reported.
Time frame: Up to Follow-up (Day 28)
Number of Participants Reaching Undetectability of virus Between First Administration of Study Drug and Day 28
Non-detectability of virus in nasal swabs between first administration of study drug and Day 28 will be reported.
Time frame: Day 1 to Day 28
Total Number of Respiratory Syncytial Virus (RSV) Hospitalization Days from Admission to Discharge
The total number of Respiratory Syncytial Virus (RSV) hospitalization days from admission to discharge will be reported.
Time frame: Up to Follow-up (Day 28)
Total RSV Hospitalization Days with Supplemental Oxygen Requirement
The total number of RSV Hospitalization Days with Supplemental Oxygen Requirement will be reported.
Time frame: Up to Follow-up (Day 28)
The Number of days in Intensive care unit (ICU) due to RSV
The number of days stayed in ICU due to RSV will be reported.
Time frame: Up to Follow-up (Day 28)
Total Days of non-invasive ventilator support During RSV Hospitalization
The total number of days with non-invasive ventilator support during RSV hospitalization will be reported.
Time frame: Up to Follow-up (Day 28)
Total Days of Mechanical Ventilation During RSV Hospitalization
The total number of days with Mechanical Ventilation during RSV hospitalization will be reported.
Time frame: Up to Follow-up (Day 28)
Changes in Peripheral Capillary Oxygen Saturation (SpO2)
The Percentage of Peripheral Capillary Oxygen Saturation (SpO2) will be assessed by the investigator during hospitalisation.
Time frame: Up to Follow-up (Day 28)
Change from Baseline in Respiratory Rate
The Respiratory rate (number of breaths per minute) will be assessed by the investigator and caregiver during hospitalisation.
Time frame: Up to Follow-up (Day 28)
Change from Baseline in Body Temperature
The body temperature (degrees Celcius) will be assessed by the investigator and caregiver during hospitalisation.
Time frame: Up to Follow-up (Day 28)
Clinical Symptom Score
The clinical symptom score will be assessed by the investigator (Clinician Outcome Assessment) and caregiver symptom Diary for each symptom. Clinical Symptom score ranges from 0 (best) to 4 (worst).
Time frame: Up to Follow-up (Day 28)
This study is terminated, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: JNJ-53718678
Respiratory Syncytial Virus Infections →