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Antiviral

A Study of JNJ-64281802 Against Dengue Serotype 1 Infection in a Dengue Human Challenge Model in Healthy Adult Participants

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -5: predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; day 21: predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours postdose

Summary

This trial is testing a drug called JNJ-64281802 to see if it can lower the amount of dengue virus in patients' bodies. The study focuses on people infected with dengue virus type 1. The goal is to see if this drug can reduce the severity of their infection by decreasing the virus levels.

Eligible Conditions
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -5: predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; day 21: predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -5: predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; day 21: predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the DENV-1 RNA VL-concentration time Curve (VL AUC) from Immediately before Inoculation (Baseline on Day 1) until Day 29
Secondary study objectives
Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau)
Area Under the Viremia Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
Area Under the log10-transformed DENV 1 RNA VL Concentration-time Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
+23 more

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: JNJ-64281802 Medium doseExperimental Treatment1 Intervention
Participants will receive medium dose of JNJ-64281802 orally.
Group II: JNJ-64281802 Low doseExperimental Treatment1 Intervention
Participants will receive low dose of JNJ-64281802 orally.
Group III: JNJ-64281802 High doseExperimental Treatment1 Intervention
Participants will receive high dose of JNJ-64281802 orally.
Group IV: JNJ-64281802 Dosing Regimen ZExperimental Treatment1 Intervention
Participants will receive dosing regimen Z of JNJ-64281802 orally.
Group V: JNJ-64281802 Dosing Regimen YExperimental Treatment1 Intervention
Participants will receive dosing regimen Y of JNJ-64281802 orally.
Group VI: JNJ-64281802 Dosing Regimen XExperimental Treatment1 Intervention
Participants will receive dosing regimen X of JNJ-64281802 orally.
Group VII: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo of JNJ-64281802 orally.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,402,370 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,980,397 Total Patients Enrolled
~0 spots leftby Sep 2027
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