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

January 9, 2025 updated by: Janssen Research & Development, LLC

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically relevant. This determination must be recorded in the participant's source documents and initialed and dated by the investigator
  • Must pass the comprehension test (i.e., obtain a passing score of greater than or equal to (>=) 75 percent (%), with up to 3 attempts in total) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, after reading the informed consent and after the investigator or designee has provided detailed information on the study and answered the potential participant's questions
  • Must have a blood pressure (after the participant is supine for >=5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, extremes included, and less than or equal to (<=) 90 mmHg diastolic at screening. Two repeat measurements are allowed in the absence of any other concerning health screening issues
  • Must have a Body mass index (BMI) (weight in kilogram divided by the square of height in meters) between 18.0 and 33.0 kilogram per meter square (kg/m^2), extremes included, and a body weight of >=50.0 kg at screening
  • All women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin) pregnancy test at screening

Exclusion Criteria:

  • Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients, to a previous vaccination, or to specific medications/animals for which antigens may be in the dengue virus (DENV)-1 challenge strain preparations, including shellfish, fetal bovine serum, L-glutamine, neomycin, and streptomycin
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 6 months before first dose of study drug, or is currently enrolled in an investigational study, or is planning to be enrolled in an investigational study within 90 days after last dose of study drug
  • Pregnant, breastfeeding, or planning to become pregnant during the study or within 90 days after last dose of study drug
  • Plans to father a child during the study or within 90 days after last dose of study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants will receive matching placebo of JNJ-64281802 orally.
Drug: Placebo
Matching placebo will be administered orally.
Experimental: JNJ-64281802 High dose
Participants will receive high dose of JNJ-64281802 orally.
Drug: JNJ-64281802 High dose
JNJ-64281802 high dose will be administered orally.
Experimental: JNJ-64281802 Medium dose
Participants will receive medium dose of JNJ-64281802 orally.
Drug: JNJ-64281802 Medium dose
JNJ-64281802 medium dose will be administered orally.
Experimental: JNJ-64281802 Low dose
Participants will receive low dose of JNJ-64281802 orally.
Drug: JNJ-64281802 Low dose
JNJ-64281802 low dose will be administered orally.
Experimental: JNJ-64281802 Dosing Regimen X
Participants will receive dosing regimen X of JNJ-64281802 orally.
Drug: JNJ-64281802 Dosing Regimen X
JNJ-64281802 dosing regimen X will be administered orally.
Experimental: JNJ-64281802 Dosing Regimen Y
Participants will receive dosing regimen Y of JNJ-64281802 orally.
Drug: JNJ-64281802 Dosing Regimen Y
JNJ-64281802 dosing regimen Y will be administered orally.
Experimental: JNJ-64281802 Dosing Regimen Z
Participants will receive dosing regimen Z of JNJ-64281802 orally.
Drug: JNJ-64281802 Dosing Regimen Z
JNJ-64281802 dosing regimen Z will be administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area Under the DENV-1 RNA VL-concentration time Curve (VL AUC) from Immediately before Inoculation (Baseline on Day 1) until Day 29
Time Frame: Baseline to Day 29
Area under the dengue virus (DENV)-1 ribonucleic acid (RNA) Viral Load (VL) concentration-time curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported.
Baseline to Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time Frame: Up to Day 85
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to Day 85
Number of Participants with Clinically Significant Abnormalities in Physical Examination
Time Frame: Up to Day 85
Number of participants with clinically significant abnormalities in physical examination will be reported.
Up to Day 85
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time Frame: Up to Day 85
Number of participants with clinically significant abnormalities in vital signs (body temperature, pulse/heart rate, systolic and diastolic blood pressure) will be reported.
Up to Day 85
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)
Time Frame: Up to Day 21
Number of participants with clinically significant abnormalities in electrocardiogram (ECGs) will be reported.
Up to Day 21
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Time Frame: Up to Day 85
Number of participants with clinically significant abnormalities in laboratory parameters (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.
Up to Day 85
Number of Participants with DENV Infection Associated AEs
Time Frame: Up to Day 85
Number of participants with DENV infection associated AEs will be reported.
Up to Day 85
Area Under the log10-transformed DENV 1 RNA VL Concentration-time Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
Time Frame: Baseline to 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 will be reported.
Baseline to Day 29
Peak of Detectable DENV-1 RNA
Time Frame: Up to Day 85
Peak of detectable DENV-1 RNA will be reported.
Up to Day 85
Duration of Detectable DENV-1 RNA
Time Frame: Up to Day 85
Duration of detectable DENV-1 RNA will be reported.
Up to Day 85
Time to First Onset of Detectable DENV-1 RNA
Time Frame: Up to Day 85
Time to first onset of detectable DENV-1 RNA will be reported.
Up to Day 85
Number of Participants with Detectable DENV-1 RNA
Time Frame: Up to Day 85
Number of participants with detectable DENV-1 RNA will be reported.
Up to Day 85
Area Under the Viremia Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
Time Frame: Baseline to Day 29
Area under the viremia curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported.
Baseline to Day 29
Area Under the log10-transformed Viremia Curves
Time Frame: Up to Day 85
Area under the log10-transformed viremia curves will be reported.
Up to Day 85
Peak of Detectable Viremia Level
Time Frame: Up to Day 85
Peak of detectable viremia level will be reported.
Up to Day 85
Duration of Detectable Viremia
Time Frame: Up to Day 85
Duration of detectable viremia will be reported.
Up to Day 85
Time to First Onset of Detectable Viremia
Time Frame: Up to Day 85
Time to first onset of detectable viremia will be reported.
Up to Day 85
Number of Participants with Detectable Viremia
Time Frame: Up to Day 85
Number of participants with detectable viremia will be reported.
Up to Day 85
Maximum Observed Analyte Concentration (Cmax) of JNJ-64281802
Time Frame: 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
Cmax is the maximum observed analyte concentration.
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
Minimum Observed Analyte Concentration (Cmin) of JNJ-64281802
Time Frame: Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
Cmin is the minimum observed analyte concentration.
Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
Trough Plasma Analyte Concentration (Ctrough) of JNJ-64281802
Time Frame: Day -4, 1, 6, 8, 10, and 15: Predose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
(Ctrough) is defined as observed analyte concentration just prior to the beginning or at the end of a dosing interval.
Day -4, 1, 6, 8, 10, and 15: Predose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
Average Analyte Concentration (Cavg) of JNJ-64281802
Time Frame: 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
Cavg is defined as average analyte concentration over the dosing interval (tau) and will be calculated as AUCtau/Tau.
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
Time to Reach Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-64281802
Time Frame: 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
Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.
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
Fluctuation Index (FI) of JNJ-64281802
Time Frame: Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).
Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau)
Time Frame: 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
The AUCtau is the measure of the plasma analyte concentration from time zero to end of dosing interval. AUC during a dosing interval (τ), calculated by linear-linear trapezoidal summation.
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
Number of Participants with Anti DENV-1 Total IgM and IgG Antibody Titers
Time Frame: Up to Day 85
Anti-DENV-1 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies will be measured using enzyme-linked immunosorbent assay (ELISA).
Up to Day 85
Time to First Onset of Anti-DENV-1 Total IgM and IgG Antibody Titers
Time Frame: Up to Day 85
Time to first onset of anti-DENV-1 total IgM and IgG antibody titers will be reported.
Up to Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108700
  • 64281802DNG2001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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