Clinical trial NCT04480736: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: Area Under the DENV-1 RNA VL-concentration time Curve (VL AUC) from Immediately before Inoculation (Baseline on Day 1) until Day 29
timeFrame: Baseline to Day 29
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to Day 85
measure: Number of Participants with Clinically Significant Abnormalities in Physical Examination
timeFrame: Up to Day 85
measure: Number of Participants with Clinically Significant Abnormalities in Vital Signs
timeFrame: Up to Day 85
measure: Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)
timeFrame: Up to Day 21
measure: Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
timeFrame: Up to Day 85
measure: Number of Participants with DENV Infection Associated AEs
timeFrame: Up to Day 85
measure: Area Under the log10-transformed DENV 1 RNA VL Concentration-time Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
timeFrame: Baseline to Day 29
measure: Peak of Detectable DENV-1 RNA
timeFrame: Up to Day 85
measure: Duration of Detectable DENV-1 RNA
timeFrame: Up to Day 85
measure: Time to First Onset of Detectable DENV-1 RNA
timeFrame: Up to Day 85
measure: Number of Participants with Detectable DENV-1 RNA
timeFrame: Up to Day 85
measure: Area Under the Viremia Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
timeFrame: Baseline to Day 29
measure: Area Under the log10-transformed Viremia Curves
timeFrame: Up to Day 85
measure: Peak of Detectable Viremia Level
timeFrame: Up to Day 85
measure: Duration of Detectable Viremia
timeFrame: Up to Day 85
measure: Time to First Onset of Detectable Viremia
timeFrame: Up to Day 85
measure: Number of Participants with Detectable Viremia
timeFrame: Up to Day 85
measure: Maximum Observed Analyte Concentration (Cmax) of JNJ-64281802
timeFrame: 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
measure: Minimum Observed Analyte Concentration (Cmin) of JNJ-64281802
timeFrame: Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
measure: Trough Plasma Analyte Concentration (Ctrough) of JNJ-64281802
timeFrame: Day -4, 1, 6, 8, 10, and 15: Predose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
measure: Average Analyte Concentration (Cavg) of JNJ-64281802
timeFrame: 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
measure: Time to Reach Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-64281802
timeFrame: 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
measure: Fluctuation Index (FI) of JNJ-64281802
timeFrame: Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
measure: Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau)
timeFrame: 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
measure: Number of Participants with Anti DENV-1 Total IgM and IgG Antibody Titers
timeFrame: Up to Day 85
measure: Time to First Onset of Anti-DENV-1 Total IgM and IgG Antibody Titers
timeFrame: Up to Day 85
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: