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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005041-41 | EudraCT Number | ||
| 53718678RSV2001 | Other Identifier | Janssen Sciences Ireland UC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive placebo or JNJ-53718678 500 milligram (mg) or 200 mg once daily for 7 days. |
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| Cohort 2 | Experimental | Participants will receive placebo or JNJ-53718678; dosing regimen in Cohort 2 will be decided based on Cohort 1 results. |
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| Cohort 3 | Experimental | Participants will receive placebo or JNJ-53718678, 75 mg once daily for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants will receive placebo once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to Follow-up (Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Follow-up (Day 28) |
| Viral Load Over Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Sciences Ireland UC Clinical Trial | Janssen Sciences Ireland UC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29684148 | Derived | Stevens M, Rusch S, DeVincenzo J, Kim YI, Harrison L, Meals EA, Boyers A, Fok-Seang J, Huntjens D, Lounis N, Mari N K, Remmerie B, Roymans D, Koul A, Verloes R. Antiviral Activity of Oral JNJ-53718678 in Healthy Adult Volunteers Challenged With Respiratory Syncytial Virus: A Placebo-Controlled Study. J Infect Dis. 2018 Jul 24;218(5):748-756. doi: 10.1093/infdis/jiy227. |
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| JNJ-53718678 | Drug | 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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| Baseline up to Follow-up (Day 28) |
| Peak Viral Load | Baseline up to Follow-up (Day 28) |
| Time To Peak Viral Load | Time to peak viral load will be reported. | 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 | 24 hours after first dose |
| Area Under the Viral Load-time Curve (VL AUC) From Time 0 to 48 Hours after First Dose | 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. | Baseline up to Follow-up (Day 28) |
| Total Clinical Symptom Score | 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). | Admission (Day -1 or -2) up to Day 13 |
| Time to Peak Symptom Score After Viral Inoculation | Admission (Day -1 or -2) up to Day 13 |
| Mucus Weight | Baseline up to Day 13 |
| Tissue Count | Baseline up to Day 13 |
| Sequence Analysis of the Rsv-A Memphis 37b Genome | Baseline and post-Baseline |
| Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry | 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. | Baseline up to Follow-up (Day 28) |
| Forced Vital Capacity (FVC) Measured by Spirometry | FVC is the total volume of air expired after a full inspiration. | Baseline up to Follow-up (Day 28) |
| FEV1/FVC Ratio | Baseline up to Follow-up (Day 28) |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000624632 | JNJ-53718678 |
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