NCT04480736

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

A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of Repeated Oral Doses of JNJ-64281802 Against Dengue Serotype 1 Infection in a Dengue Human Challenge Model in Healthy Adult Participants

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the antiviral activity of JNJ-64281802 versus placebo in terms of reduction of dengue virus 1 (DENV-1) ribonucleic acid (RNA) viral load (VL).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo will be administered orally.
DRUG	JNJ-64281802 High dose	JNJ-64281802 high dose will be administered orally.
DRUG	JNJ-64281802 Medium dose	JNJ-64281802 medium dose will be administered orally.
DRUG	JNJ-64281802 Low dose	JNJ-64281802 low dose will be administered orally.
DRUG	JNJ-64281802 Dosing Regimen X	JNJ-64281802 dosing regimen X will be administered orally.
DRUG	JNJ-64281802 Dosing Regimen Y	JNJ-64281802 dosing regimen Y will be administered orally.
DRUG	JNJ-64281802 Dosing Regimen Z	JNJ-64281802 dosing regimen Z will be administered orally.

Timeline

• Start date: 2020-07-28
• Primary completion: 2027-09-02
• Completion: 2027-12-09
• First posted: 2020-07-21
• Last updated: 2025-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study