Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Rilematovir, Formulation B, Formulation C, Formulation D, Formulation E, Formulation F, Formulation M1, Formulation M2
JNJ-53718678 · 4 trials · 3 indications
RSV viral load AUC was determined from immediately prior to first dose of JNJ-53718678 through Day 5. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.
Area under the RSV VL-time curve (AUC) was determined as log10 copies\*hour per milliliter (Log10 copies\*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs.
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.
Percentage of participants with undetectable RSV viral load at Day 3 were reported.
Percentage of participants with undetectable RSV viral load at Day 5 were reported.
Percentage of participants with undetectable RSV viral load at Day 8 were reported.
Percentage of participants with undetectable RSV viral load at Day 14 were reported.
Percentage of participants with undetectable RSV viral load at Day 21 were reported.
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.
Cmax is defined as maximum observed plasma analyte concentration of rilematovir.
Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration of rilematovir.
T1/2 is defined as the apparent terminal elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve.
AUC(0-last) is defined as area under the plasma analyte concentration versus time curve from time zero to the time of the last measurable concentration of rilematovir.
AUC(0-infinity) is defined as area under the plasma analyte concentration versus time curve from time zero to infinite time of rilematovir.
CL/F is defined as total apparent oral clearance of rilematovir.
| Arm | Type | Description |
|---|---|---|
| Part 1-Observational Phase | OTHER | Participants will not receive any intervention in the observation phase. All infants will be closely monitored for early signs and symptoms of Respiratory Syncytial Virus (RSV) disease using a mobile RSV application on the parent/caregiver's mobile phone, upon an alert, the RSV will be tested, if RSV negative participants (RSV \[-\] diagnosed at site) will return to the pre-diagnostic phase and RSV positive participants (RSV \[+\] diagnosed at site) can be enrolled in the interventional stage of the study after obtaining informed consent for the interventional stage at that time. RSV (+) participants whose parent(s)/caregiver(s) do not consent for enrollment in the interventional stage and participants who are screening failures in the interventional stage will enter the post-diagnostic phase of the observational stage (hospitalized or outpatients). |
| Part 2-Interventional Phase | EXPERIMENTAL | Participants will be randomized to receive either JNJ-53718678 (for Age Group 1 (greater than or equal to \[\>=\] 28 days and less than \[\<\] 3 months): 2.5 milligram per kilogram \[mg/kg\]; for Age Group 2 (\>=3 and \<6 months): 3 mg/kg and for Age Group 3 (\>=6 months): 4.5 mg/kg) or placebo (Age Group 1, 2 and 3) twice daily for 7 days. |
| Treatment A: JNJ-53718678 500 mg | EXPERIMENTAL | Participants will receive 500 mg dose of JNJ-53718678 once daily for 7 days. |
| Treatment B: JNJ-53718678 80 mg + Placebo | EXPERIMENTAL | Participants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days. |
| Treatment C: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days. |
| Cohort 1 | EXPERIMENTAL | Participants will receive placebo or JNJ-53718678 500 milligram (mg) or 200 mg once daily for 7 days. |
| Cohort 2 | EXPERIMENTAL | Participants will receive placebo or JNJ-53718678; dosing regimen in Cohort 2 will be decided based on Cohort 1 results. |
| Cohort 3 | EXPERIMENTAL | Participants will receive placebo or JNJ-53718678, 75 mg once daily for 7 days. |
| Treatment Sequence ABC | EXPERIMENTAL | Participants will receive a single oral dose of rilematovir (Treatment A) in Treatment Period 1, followed by a single oral dose of ciclosporin (Treatment B) in Treatment Period 2 and then single oral dose of ciclosporin plus single oral dose of rilematovir (Treatment C) in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention. |
| Treatment Sequence BCA | EXPERIMENTAL | Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention. |
| Treatment Sequence CAB | EXPERIMENTAL | Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention. |
| Treatment Sequence ACB | EXPERIMENTAL | Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention. |
| Treatment Sequence BAC | EXPERIMENTAL | Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment C in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention. |
| Treatment Sequence CBA | EXPERIMENTAL | Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention. |
| Name | Type | Description |
|---|---|---|
| RSV Mobile Application | OTHER | Participants will not receive any intervention in observational phase of this study. Participant's respiratory symptoms will be captured by RSV mobile application installed in participant's caregiver/parent mobile phone. |
| Placebo | DRUG | Participants in each Age Group (1,2,3) will receive matching placebo (volume placebo to match the calculated volume of the JNJ-53718678 dose) orally twice daily for 7 days. |
| JNJ-53718678 2.5 mg/kg | DRUG | JNJ-53718678 will be administered to Age Group 1 twice daily for 7 days. |
| JNJ-53718678 3 mg/kg | DRUG | JNJ-53718678 will be administered to Age Group 2 twice daily for 7 days. |
| JNJ-53718678 4.5 mg/kg | DRUG | JNJ-53718678 will be administered to Age Group 3 twice daily for 7 days. |
| JNJ-53718678 500 mg | DRUG | Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days. |
| JNJ-53718678 80 mg | DRUG | Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days. |
| 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. |
| Rilematovir | DRUG | Rilematovir will be administered orally as per assigned treatment sequence. |
| Ciclosporin | DRUG | Ciclosporin will be administered orally as per assigned treatment sequence. |
Inclusion Criteria: Part 1: Observational Stage * The infant is less than or equal to (\<=) 4 months of age at enrollment and asymptomatic for acute respiratory illness (ARI)-like symptoms requiring medical intervention at the time of consent to participate in the study * At least 1 parent/caregiv...
JNJ-53718678 is an investigational antiviral medicine being studied for the treatment of respiratory syncytial virus infections. It has been evaluated in adults with RSV infection and in infants with RSV acute respiratory tract disease. It is not approved for any use and remains in clinical development.
JNJ-53718678 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company has sponsored the clinical studies of the compound in respiratory syncytial virus infection.
JNJ-53718678 is in Phase 2 clinical development. Two Phase 2 studies have been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA or any other regulatory agency for the treatment of respiratory syncytial virus infection.
JNJ-53718678 has been studied in completed Phase 2 trials. NCT03379675 tested two dose levels in non-hospitalized adults with RSV, NCT02387606 evaluated repeated oral doses against RSV infection, and NCT04068792 was a two-part infant study for early RSV diagnosis and treatment. Total enrollment across these studies was 138 participants.
JNJ-53718678 is a small molecule antiviral directed against respiratory syncytial virus. It is designed to interfere with the virus itself rather than a human protein target, which is why it is classified as a direct-acting antiviral agent for RSV infection.