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NCT05048875

An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge

Completed Phase 2 Results posted Last updated 24 April 2025
What this trial tests

Phase 2 trial testing Cohort 1 - Group 1 JNJ High Dose in Dengue in 56 participants. Completed in 10 September 2024.

Timeline
3 February 2022
Primary endpoint
16 May 2023
10 September 2024

Quick facts

Lead sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingtriple
Primary purposeprevention
Enrollment56
Start date3 February 2022
Primary completion16 May 2023
Estimated completion10 September 2024
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 55, any sex, with Dengue. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Assess the Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo in Terms of Reduction of Dengue Infection. Primary · 28 days

Area under the DENV-3 RNA viral load (VL) concentration-time curves from immediately before inoculation (baseline on Day 1) until Day 29. Cohort 2 was recently unblinded (data analysis is in process) and Cohort 2 is not part of the primary outcome assessment. Therefore, it cannot yet be fully represented in the record (i.e., results).

GroupValue95% CI
Cohort 1 Group 1 - JNJ High Dose3.002.4 – 3.6
Cohort 1 Group 2 - JNJ Low Dose5.24.5 – 5.9
Cohort 1 Group 2 - JNJ Medium Dose4.74.0 – 5.4
Cohort 1 Group 1/2 Placebo5.04.4 – 5.6
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802). Secondary · 85 Days
Participants with 1 or more AE (Any AE)
GroupValue95% CI
Cohort 1 - Group 1 JNJ High Dose11
Cohort 1 - Group 2 JNJ Medium Dose6
Cohort 1 - Group 2 JNJ Low Dose6
Cohort 1 Group 1 Placebo and Cohort 1 Group 2 Placebo8
Cohort 2 - Group 3 JNJ Daily Dose6
Cohort 2 - Group 4 JNJ Weekly Dose7
Cohort 2 - Group 5 JNJ Weekly Dose6
Cohort 2 - Group 3, Group 4, and Group 5 Placebo6
Participants with 1 or more AE related to study treatment
GroupValue95% CI
Cohort 1 - Group 1 JNJ High Dose5
Cohort 1 - Group 2 JNJ Medium Dose4
Cohort 1 - Group 2 JNJ Low Dose3
Cohort 1 Group 1 Placebo and Cohort 1 Group 2 Placebo3
Cohort 2 - Group 3 JNJ Daily Dose1
Cohort 2 - Group 4 JNJ Weekly Dose0
Cohort 2 - Group 5 JNJ Weekly Dose3
Cohort 2 - Group 3, Group 4, and Group 5 Placebo2
Participants with 1 or more AE related to inoculation with DENV-3
GroupValue95% CI
Cohort 1 - Group 1 JNJ High Dose3
Cohort 1 - Group 2 JNJ Medium Dose5
Cohort 1 - Group 2 JNJ Low Dose5
Cohort 1 Group 1 Placebo and Cohort 1 Group 2 Placebo5
Cohort 2 - Group 3 JNJ Daily Dose0
Cohort 2 - Group 4 JNJ Weekly Dose3
Cohort 2 - Group 5 JNJ Weekly Dose2
Cohort 2 - Group 3, Group 4, and Group 5 Placebo4
Participants with 1 or more AE leading to discontinuation of any study treatment
GroupValue95% CI
Cohort 1 - Group 1 JNJ High Dose0
Cohort 1 - Group 2 JNJ Medium Dose0
Cohort 1 - Group 2 JNJ Low Dose0
Cohort 1 Group 1 Placebo and Cohort 1 Group 2 Placebo1
Cohort 2 - Group 3 JNJ Daily Dose0
Cohort 2 - Group 4 JNJ Weekly Dose0
Cohort 2 - Group 5 JNJ Weekly Dose0
Cohort 2 - Group 3, Group 4, and Group 5 Placebo0
Participants with 1 or more AE leading to termination of study participation
GroupValue95% CI
Cohort 1 - Group 1 JNJ High Dose0
Cohort 1 - Group 2 JNJ Medium Dose0
Cohort 1 - Group 2 JNJ Low Dose0
Cohort 1 Group 1 Placebo and Cohort 1 Group 2 Placebo1
Cohort 2 - Group 3 JNJ Daily Dose0
Cohort 2 - Group 4 JNJ Weekly Dose0
Cohort 2 - Group 5 JNJ Weekly Dose0
Cohort 2 - Group 3, Group 4, and Group 5 Placebo0
Participants with 1 or more AE of Mild severity
GroupValue95% CI
Cohort 1 - Group 1 JNJ High Dose5
Cohort 1 - Group 2 JNJ Medium Dose2
Cohort 1 - Group 2 JNJ Low Dose2
Cohort 1 Group 1 Placebo and Cohort 1 Group 2 Placebo3
Cohort 2 - Group 3 JNJ Daily Dose5
Cohort 2 - Group 4 JNJ Weekly Dose5
Cohort 2 - Group 5 JNJ Weekly Dose4
Cohort 2 - Group 3, Group 4, and Group 5 Placebo3
Participants with 1 or more AE of Moderate severity
GroupValue95% CI
Cohort 1 - Group 1 JNJ High Dose5
Cohort 1 - Group 2 JNJ Medium Dose3
Cohort 1 - Group 2 JNJ Low Dose4
Cohort 1 Group 1 Placebo and Cohort 1 Group 2 Placebo4
Cohort 2 - Group 3 JNJ Daily Dose1
Cohort 2 - Group 4 JNJ Weekly Dose0
Cohort 2 - Group 5 JNJ Weekly Dose2
Cohort 2 - Group 3, Group 4, and Group 5 Placebo0
Participants with 1 or more AE of Severe severity
GroupValue95% CI
Cohort 1 - Group 1 JNJ High Dose0
Cohort 1 - Group 2 JNJ Medium Dose0
Cohort 1 - Group 2 JNJ Low Dose1
Cohort 1 Group 1 Placebo and Cohort 1 Group 2 Placebo1
Cohort 2 - Group 3 JNJ Daily Dose0
Cohort 2 - Group 4 JNJ Weekly Dose2
Cohort 2 - Group 5 JNJ Weekly Dose0
Cohort 2 - Group 3, Group 4, and Group 5 Placebo3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

JNJ-64281802 High Dose
Serious: 0/11 (0%)
Deaths: 0/11
Placebo Cohort 1
Serious: 1/8 (13%)
Deaths: 0/8
JNJ-64281802 Medium Dose
Serious: 0/6 (0%)
Deaths: 0/6
JNJ-64281802 Low Dose
Serious: 0/6 (0%)
Deaths: 0/6
JNJ-64281802 Daily Dose (Cohort 2 Group 3)
Serious: 0/6 (0%)
Deaths: 0/6
JNJ-64281802 Weekly Dose (Cohort 2 Group 4)
Serious: 1/7 (14%)
Deaths: 0/7
JNJ-64281802 Weekly Dose (Cohort 2 Group 5)
Serious: 0/6 (0%)
Deaths: 0/6
Placebo Cohort 2
Serious: 0/6 (0%)
Deaths: 0/6

Serious adverse events (3 terms)

ReactionSystemJNJ-64281802 High DosePlacebo Cohort 1JNJ-64281802 Medium DoseJNJ-64281802 Low DoseJNJ-64281802 Daily Dose (C…JNJ-64281802 Weekly Dose (…JNJ-64281802 Weekly Dose (…Placebo Cohort 2
Creatinine Kinase HighMusculoskeletal and connective tissue disorders————————
AST increasedGastrointestinal disorders————————
Drug overdosePsychiatric disorders————————
Other adverse events (15 terms — click to expand)

ReactionSystemJNJ-64281802 High DosePlacebo Cohort 1JNJ-64281802 Medium DoseJNJ-64281802 Low DoseJNJ-64281802 Daily Dose (C…JNJ-64281802 Weekly Dose (…JNJ-64281802 Weekly Dose (…Placebo Cohort 2
Dengue-like rashInfections and infestations————————
HeadacheGeneral disorders————————
MyalgiaInfections and infestations————————
FatigueInfections and infestations————————
NauseaInfections and infestations————————
Retroorbital PainInfections and infestations————————
NeutropeniaInfections and infestations————————
Elevated ALTInfections and infestations————————
ArthalgiaInfections and infestations————————
Increased CholesterolInvestigations————————
FeverGeneral disorders————————
Local TendernessInvestigations————————
Prolonged PTInvestigations————————
Prolonged PTTInvestigations————————
Elevated lipaseGastrointestinal disorders————————

Most-reported serious reactions: Creatinine Kinase High, AST increased, Drug overdose.

Data from ClinicalTrials.gov NCT05048875 adverse events section.

Sponsor's own description

The investigational study drug, JNJ-64281802, is being developed for the prevention and treatment of dengue infection. This study is hypothesizing that the highest dose of the investigational study drug is superior to receiving a placebo with respect to its antiviral activity in healthy adult participants inoculated with Dengue Serotype 3.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Molecular Mechanisms of Antiviral Agents against Dengue Virus.
    Lee MF, Wu YS, Poh CL. · · 2023 · cited 66× · PMID 36992414 · DOI 10.3390/v15030705
  2. The pipeline for drugs for control and elimination of neglected tropical diseases: 1. Anti-infective drugs for regulatory registration.
    Pfarr KM, Krome AK, Al-Obaidi I, Batchelor H, et al · · 2023 · cited 20× · PMID 36859332 · DOI 10.1186/s13071-022-05581-4
  3. Daily Mosnodenvir as Dengue Prophylaxis in a Controlled Human Infection Model.
    Durbin AP, Van Wesenbeeck L, Pierce KK, Herrera-Taracena G, et al · · 2025 · cited 9× · PMID 41297006 · DOI 10.1056/nejmoa2500179
  4. Inhibitory Potential of Chromene Derivatives on Structural and Non-Structural Proteins of Dengue Virus.
    Dharmapalan BT, Biswas R, Sankaran S, Venkidasamy B, et al · · 2022 · cited 7× · PMID 36560664 · DOI 10.3390/v14122656
  5. Dengue virus: pathogenesis and potential for small molecule inhibitors.
    Chauhan N, Gaur KK, Asuru TR, Guchhait P. · · 2024 · cited 6× · PMID 39051974 · DOI 10.1042/bsr20240134
  6. Orthoflaviviral Inhibitors in Clinical Trials, Preclinical In Vivo Efficacy Targeting NS2B-NS3 and Cellular Antiviral Activity via Competitive Protease Inhibition.
    Cavina L, Bouma MJ, Gironés D, Feiters MC. · · 2024 · cited 5× · PMID 39274895 · DOI 10.3390/molecules29174047
  7. Exploiting host kinases to combat dengue virus infection and disease.
    Bourgeois NM, Wei L, Kaushansky A, Aitchison JD. · · 2025 · cited 1× · PMID 40348023 · DOI 10.1016/j.antiviral.2025.106172

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