Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-53718678/kg · 1 trial · 1 indication
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.
| 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. |
| 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. |
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 small molecule being studied for respiratory syncytial virus (RSV) infections and in healthy volunteers. It is in Phase 1 clinical development and is not approved by the FDA. The drug is being evaluated for its safety, tolerability, and pharmacokinetics in early-stage trials.
JNJ-53718678 is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics and drug interactions in healthy participants. All six completed trials were sponsored by Johnson & Johnson.
JNJ-53718678 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug has completed six Phase 1 trials, with no active trials currently ongoing. These trials focused on healthy volunteers to assess safety and how the drug is processed by the body.
JNJ-53718678 has completed six Phase 1 trials, including NCT02729467, NCT02945007, NCT03002779, and NCT04090086. These studies assessed drug interactions, bioavailability, food effects, and metabolism in healthy adults. The trials were conducted in the United States, Belgium, and the Netherlands, with a total enrollment of 213 participants.
No, JNJ-53718678 is not the same as JNJ-64417184. They are separate investigational drugs. A completed clinical trial, NCT04090086, studied the interaction between JNJ-64417184 and JNJ-53718678 after single and multiple dosing in healthy participants, indicating they are distinct compounds being evaluated together.