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

NCT04480736 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: CR10870064281802DNG2001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Day 29

Secondary Outcomes (26)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to Day 85

• Number of Participants with Clinically Significant Abnormalities in Physical Examination

  Up to Day 85

• Number of Participants with Clinically Significant Abnormalities in Vital Signs

  Up to Day 85

• Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)

  Up to Day 21

• Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters

  Up to Day 85

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo of JNJ-64281802 orally.

Drug: Placebo

JNJ-64281802 High dose

EXPERIMENTAL

Participants will receive high dose of JNJ-64281802 orally.

Drug: JNJ-64281802 High dose

JNJ-64281802 Medium dose

EXPERIMENTAL

Participants will receive medium dose of JNJ-64281802 orally.

Drug: JNJ-64281802 Medium dose

JNJ-64281802 Low dose

EXPERIMENTAL

Participants will receive low dose of JNJ-64281802 orally.

Drug: JNJ-64281802 Low dose

JNJ-64281802 Dosing Regimen X

EXPERIMENTAL

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

Drug: JNJ-64281802 Dosing Regimen X

JNJ-64281802 Dosing Regimen Y

EXPERIMENTAL

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

Drug: JNJ-64281802 Dosing Regimen Y

JNJ-64281802 Dosing Regimen Z

EXPERIMENTAL

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

Drug: JNJ-64281802 Dosing Regimen Z

Interventions

Placebo DRUG

Matching placebo will be administered orally.

Placebo

JNJ-64281802 High dose DRUG

JNJ-64281802 high dose will be administered orally.

JNJ-64281802 High dose

JNJ-64281802 Medium dose DRUG

JNJ-64281802 medium dose will be administered orally.

JNJ-64281802 Medium dose

JNJ-64281802 Low dose DRUG

JNJ-64281802 low dose will be administered orally.

JNJ-64281802 Low dose

JNJ-64281802 Dosing Regimen X DRUG

JNJ-64281802 dosing regimen X will be administered orally.

JNJ-64281802 Dosing Regimen X

JNJ-64281802 Dosing Regimen Y DRUG

JNJ-64281802 dosing regimen Y will be administered orally.

JNJ-64281802 Dosing Regimen Y

JNJ-64281802 Dosing Regimen Z DRUG

JNJ-64281802 dosing regimen Z will be administered orally.

JNJ-64281802 Dosing Regimen Z

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 21, 2020
• Study Start: July 28, 2020
• Primary Completion (Estimated): September 2, 2027
• Study Completion (Estimated): December 9, 2027
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)