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

Primary Purpose

Healthy

Status
Suspended
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
JNJ-64281802 High dose
JNJ-64281802 Medium dose
JNJ-64281802 Low dose
JNJ-64281802 Dosing Regimen X
JNJ-64281802 Dosing Regimen Y
JNJ-64281802 Dosing Regimen Z
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SUNY Upstate Medical University
  • hVIVO Services Limited

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

JNJ-64281802 High dose

JNJ-64281802 Medium dose

JNJ-64281802 Low dose

JNJ-64281802 Dosing Regimen X

JNJ-64281802 Dosing Regimen Y

JNJ-64281802 Dosing Regimen Z

Arm Description

Participants will receive matching placebo of JNJ-64281802 orally.

Participants will receive high dose of JNJ-64281802 orally.

Participants will receive medium dose of JNJ-64281802 orally.

Participants will receive low dose of JNJ-64281802 orally.

Participants will receive dosing regimen X of JNJ-64281802 orally.

Participants will receive dosing regimen Y of JNJ-64281802 orally.

Participants will receive dosing regimen Z of JNJ-64281802 orally.

Outcomes

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
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.

Secondary Outcome Measures

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
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.
Number of Participants with Clinically Significant Abnormalities in Physical Examination
Number of participants with clinically significant abnormalities in physical examination will be reported.
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Number of participants with clinically significant abnormalities in vital signs (body temperature, pulse/heart rate, systolic and diastolic blood pressure) will be reported.
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)
Number of participants with clinically significant abnormalities in electrocardiogram (ECGs) will be reported.
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Number of participants with clinically significant abnormalities in laboratory parameters (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.
Number of Participants with DENV Infection Associated AEs
Number of participants with DENV infection associated AEs will be reported.
Area Under the log10-transformed DENV 1 RNA VL Concentration-time 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 will be reported.
Peak of Detectable DENV-1 RNA
Peak of detectable DENV-1 RNA will be reported.
Duration of Detectable DENV-1 RNA
Duration of detectable DENV-1 RNA will be reported.
Time to First Onset of Detectable DENV-1 RNA
Time to first onset of detectable DENV-1 RNA will be reported.
Number of Participants with Detectable DENV-1 RNA
Number of participants with detectable DENV-1 RNA will be reported.
Area Under the Viremia Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
Area under the viremia curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported.
Area Under the log10-transformed Viremia Curves
Area under the log10-transformed viremia curves will be reported.
Peak of Detectable Viremia Level
Peak of detectable viremia level will be reported.
Duration of Detectable Viremia
Duration of detectable viremia will be reported.
Time to First Onset of Detectable Viremia
Time to first onset of detectable viremia will be reported.
Number of Participants with Detectable Viremia
Number of participants with detectable viremia will be reported.
Maximum Observed Analyte Concentration (Cmax) of JNJ-64281802
Cmax is the maximum observed analyte concentration.
Minimum Observed Analyte Concentration (Cmin) of JNJ-64281802
Cmin is the minimum observed analyte concentration.
Trough Plasma Analyte Concentration (Ctrough) of JNJ-64281802
(Ctrough) is defined as observed analyte concentration just prior to the beginning or at the end of a dosing interval.
Average Analyte Concentration (Cavg) of JNJ-64281802
Cavg is defined as average analyte concentration over the dosing interval (tau) and will be calculated as AUCtau/Tau.
Time to Reach Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-64281802
Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.
Fluctuation Index (FI) of JNJ-64281802
FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).
Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau)
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.
Number of Participants with Anti DENV-1 Total IgM and IgG Antibody Titers
Anti-DENV-1 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies will be measured using enzyme-linked immunosorbent assay (ELISA).
Time to First Onset of Anti-DENV-1 Total IgM and IgG Antibody Titers
Time to first onset of anti-DENV-1 total IgM and IgG antibody titers will be reported.

Full Information

First Posted
July 17, 2020
Last Updated
February 14, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04480736
Brief Title
A Study of JNJ-64281802 Against Dengue Serotype 1 Infection in a Dengue Human Challenge Model in Healthy Adult Participants
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
The decision has been taken to PAUSE DNG2001 recruitment.
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
April 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo of JNJ-64281802 orally.
Arm Title
JNJ-64281802 High dose
Arm Type
Experimental
Arm Description
Participants will receive high dose of JNJ-64281802 orally.
Arm Title
JNJ-64281802 Medium dose
Arm Type
Experimental
Arm Description
Participants will receive medium dose of JNJ-64281802 orally.
Arm Title
JNJ-64281802 Low dose
Arm Type
Experimental
Arm Description
Participants will receive low dose of JNJ-64281802 orally.
Arm Title
JNJ-64281802 Dosing Regimen X
Arm Type
Experimental
Arm Description
Participants will receive dosing regimen X of JNJ-64281802 orally.
Arm Title
JNJ-64281802 Dosing Regimen Y
Arm Type
Experimental
Arm Description
Participants will receive dosing regimen Y of JNJ-64281802 orally.
Arm Title
JNJ-64281802 Dosing Regimen Z
Arm Type
Experimental
Arm Description
Participants will receive dosing regimen Z of JNJ-64281802 orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be administered orally.
Intervention Type
Drug
Intervention Name(s)
JNJ-64281802 High dose
Intervention Description
JNJ-64281802 high dose will be administered orally.
Intervention Type
Drug
Intervention Name(s)
JNJ-64281802 Medium dose
Intervention Description
JNJ-64281802 medium dose will be administered orally.
Intervention Type
Drug
Intervention Name(s)
JNJ-64281802 Low dose
Intervention Description
JNJ-64281802 low dose will be administered orally.
Intervention Type
Drug
Intervention Name(s)
JNJ-64281802 Dosing Regimen X
Intervention Description
JNJ-64281802 dosing regimen X will be administered orally.
Intervention Type
Drug
Intervention Name(s)
JNJ-64281802 Dosing Regimen Y
Intervention Description
JNJ-64281802 dosing regimen Y will be administered orally.
Intervention Type
Drug
Intervention Name(s)
JNJ-64281802 Dosing Regimen Z
Intervention Description
JNJ-64281802 dosing regimen Z will be administered orally.
Primary Outcome Measure Information:
Title
Area Under the DENV-1 RNA VL-concentration time Curve (VL AUC) from Immediately before Inoculation (Baseline on Day 1) until Day 29
Description
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.
Time Frame
Baseline to Day 29
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Description
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.
Time Frame
Up to Day 85
Title
Number of Participants with Clinically Significant Abnormalities in Physical Examination
Description
Number of participants with clinically significant abnormalities in physical examination will be reported.
Time Frame
Up to Day 85
Title
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Description
Number of participants with clinically significant abnormalities in vital signs (body temperature, pulse/heart rate, systolic and diastolic blood pressure) will be reported.
Time Frame
Up to Day 85
Title
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)
Description
Number of participants with clinically significant abnormalities in electrocardiogram (ECGs) will be reported.
Time Frame
Up to Day 21
Title
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Description
Number of participants with clinically significant abnormalities in laboratory parameters (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.
Time Frame
Up to Day 85
Title
Number of Participants with DENV Infection Associated AEs
Description
Number of participants with DENV infection associated AEs will be reported.
Time Frame
Up to Day 85
Title
Area Under the log10-transformed DENV 1 RNA VL Concentration-time Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
Description
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.
Time Frame
Baseline to Day 29
Title
Peak of Detectable DENV-1 RNA
Description
Peak of detectable DENV-1 RNA will be reported.
Time Frame
Up to Day 85
Title
Duration of Detectable DENV-1 RNA
Description
Duration of detectable DENV-1 RNA will be reported.
Time Frame
Up to Day 85
Title
Time to First Onset of Detectable DENV-1 RNA
Description
Time to first onset of detectable DENV-1 RNA will be reported.
Time Frame
Up to Day 85
Title
Number of Participants with Detectable DENV-1 RNA
Description
Number of participants with detectable DENV-1 RNA will be reported.
Time Frame
Up to Day 85
Title
Area Under the Viremia Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
Description
Area under the viremia curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported.
Time Frame
Baseline to Day 29
Title
Area Under the log10-transformed Viremia Curves
Description
Area under the log10-transformed viremia curves will be reported.
Time Frame
Up to Day 85
Title
Peak of Detectable Viremia Level
Description
Peak of detectable viremia level will be reported.
Time Frame
Up to Day 85
Title
Duration of Detectable Viremia
Description
Duration of detectable viremia will be reported.
Time Frame
Up to Day 85
Title
Time to First Onset of Detectable Viremia
Description
Time to first onset of detectable viremia will be reported.
Time Frame
Up to Day 85
Title
Number of Participants with Detectable Viremia
Description
Number of participants with detectable viremia will be reported.
Time Frame
Up to Day 85
Title
Maximum Observed Analyte Concentration (Cmax) of JNJ-64281802
Description
Cmax is the maximum observed analyte concentration.
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
Title
Minimum Observed Analyte Concentration (Cmin) of JNJ-64281802
Description
Cmin is the minimum observed analyte concentration.
Time Frame
Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
Title
Trough Plasma Analyte Concentration (Ctrough) of JNJ-64281802
Description
(Ctrough) is defined as observed analyte concentration just prior to the beginning or at the end of a dosing interval.
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
Title
Average Analyte Concentration (Cavg) of JNJ-64281802
Description
Cavg is defined as average analyte concentration over the dosing interval (tau) and will be calculated as AUCtau/Tau.
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
Title
Time to Reach Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-64281802
Description
Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.
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
Title
Fluctuation Index (FI) of JNJ-64281802
Description
FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).
Time Frame
Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
Title
Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau)
Description
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.
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
Title
Number of Participants with Anti DENV-1 Total IgM and IgG Antibody Titers
Description
Anti-DENV-1 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies will be measured using enzyme-linked immunosorbent assay (ELISA).
Time Frame
Up to Day 85
Title
Time to First Onset of Anti-DENV-1 Total IgM and IgG Antibody Titers
Description
Time to first onset of anti-DENV-1 total IgM and IgG antibody titers will be reported.
Time Frame
Up to Day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
hVIVO Services Limited
City
London
ZIP/Postal Code
E1 1JT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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