CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Cohort 1 - Group 1 JNJ High Dose +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05048875
NCT05048875Phase 2Completed
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Phase 2a, Randomized, Doubleblind, Placebo-controlled Trial Evaluating the Antiviral Activity, Safety and Pharmacokinetics of Repeated Oral Doses of JNJ-64281802 Against Dengue-3 Infection in a Dengue Human Challenge Model in Healthy Adults

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Sep 17, 2021·Updated Apr 24, 2025

In Brief

A Phase 2 clinical trial evaluating Cohort 1 - Group 1 JNJ High Dose, Cohort 1 - Group 2 JNJ Medium Dose, and 2 other interventions for Dengue. Completed, enrolled 56 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue
CountriesUnited States
CollaboratorsJanssen, LP, National Institutes of Health (NIH)

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedSep 17, 2021
Enrollment StartFeb 3, 2022
Primary CompletionMay 16, 2023
Study CompletionSep 10, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.8 years ago

Interventions

Cohort 1 - Group 1 JNJ High Dosedrug

High dose: 600-mg loading dose for 5 days/200-mg maintenance dose for 21 days

Cohort 1 - Group 2 JNJ Medium Dosedrug

Medium dose: 200-mg loading dose for 5 days/50-mg maintenance dose for 21 days

Cohort 1 - Group 2 JNJ Low Dosedrug

Low dose: 40-mg loading dose for 5 days/10-mg maintenance dose for 21 days

Cohort 1 - Group 1/2 Placebodrug

Matching placebo. Note Group 1 placebo and group 2 placebo are combined per sponsor data analysis.