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

NCT05048875 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-04-24

Study results available
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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.

Conditions

  • Dengue

Interventions

DRUG

Cohort 1 - Group 1 JNJ High Dose

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

DRUG

Cohort 1 - Group 2 JNJ Medium Dose

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

DRUG

Cohort 1 - Group 2 JNJ Low Dose

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

DRUG

Cohort 1 - Group 1/2 Placebo

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

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Anna Durbin, MD · Center for Immunization Research, Johns Hopkins School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-03
Primary Completion
2023-05-16
Completion
2024-09-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05048875 on ClinicalTrials.gov