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Antiviral
JNJ-64281802 Dosing Regimen Y for Healthy Subjects
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
Awards & highlights
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 weeks3 visits
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
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under the DENV-1 RNA VL-concentration time Curve (VL AUC) from Immediately before Inoculation (Baseline on Day 1) until Day 29
Secondary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,384,239 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,893 Total Patients Enrolled
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