An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge
Phase 2a, Randomized, Doubleblind, Placebo-controlled Trial Evaluating the Antiviral Activity, Safety and Pharmacokinetics of Repeated Oral Doses of JNJ-64281802 Against Dengue-3 Infection in a Dengue Human Challenge Model in Healthy Adults
3 other identifiers
interventional
56
1 country
2
Brief Summary
The investigational study drug, JNJ-64281802, is being developed for the prevention and treatment of dengue infection. This study is hypothesizing that the highest dose of the investigational study drug is superior to receiving a placebo with respect to its antiviral activity in healthy adult participants inoculated with Dengue Serotype 3.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2021
CompletedFirst Posted
Study publicly available on registry
September 17, 2021
CompletedStudy Start
First participant enrolled
February 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2024
CompletedResults Posted
Study results publicly available
April 24, 2025
CompletedApril 24, 2025
April 1, 2025
1.3 years
June 30, 2021
May 16, 2024
April 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess the Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo in Terms of Reduction of Dengue Infection.
Area under the DENV-3 RNA viral load (VL) concentration-time curves from immediately before inoculation (baseline on Day 1) until Day 29. Cohort 2 was recently unblinded (data analysis is in process) and Cohort 2 is not part of the primary outcome assessment. Therefore, it cannot yet be fully represented in the record (i.e., results).
28 days
Secondary Outcomes (31)
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
85 Days
Physical Examinations to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
99 weeks
Recording of Vital Signs to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
99 weeks
12-lead ECG With Measurement of QTcF to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
99 weeks
12-lead ECG With Measurement of QRS Interval to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
99 weeks
- +26 more secondary outcomes
Study Arms (4)
Cohort 1 - Group 1 JNJ High Dose
EXPERIMENTALSentinel high-dose. Four participants will be enrolled in Group 1a before enrolling the remaining participants to Group 1b (12 participants total in Group 1, all same dosing regimen). Note group 1a and group 1b are combined into one arm, because the dosing regimen is the same and they were not separated during final statistical analysis.
Cohort 1 - Group 2 JNJ Medium Dose
EXPERIMENTALGroup 2 includes Medium and low dose, 14 participants total. Enrolled after completion of Group 1a.
Cohort 1 - Group 2 JNJ Low Dose
EXPERIMENTALGroup 2 includes Medium and low dose, 14 participants total. Enrolled after completion of Group 1a.
Cohort 1 - Group 1/2 Placebo
PLACEBO COMPARATORMatching placebo. Note Group 1 placebo and group 2 placebo are combined per sponsor data analysis.
Interventions
High dose: 600-mg loading dose for 5 days/200-mg maintenance dose for 21 days
Medium dose: 200-mg loading dose for 5 days/50-mg maintenance dose for 21 days
Low dose: 40-mg loading dose for 5 days/10-mg maintenance dose for 21 days
Matching placebo. Note Group 1 placebo and group 2 placebo are combined per sponsor data analysis.
Eligibility Criteria
You may qualify if:
- Male or female.
- to 55 years of age, inclusive, at time of screening.
- Healthy on the basis of physical examination, medical history, and vital signs performed at screening.
- Healthy on the basis of clinical laboratory tests performed at screening.
- Must pass the comprehension assessment indicating that the participant 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 body mass index between 18.0 and 35.0 kg/m2, inclusive.
- Must have a normal electrocardiogram (ECG, test which displays a person's heartbeat) at screening.
- Must have a blood pressure (after lying face up for greater than or equal to 5 minutes) between 90 and 140 mmHg systolic and less than or equal to 90 mmHg diastolic at screening.
- Must complete the informed consent process independently and without assistance and sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- All persons of childbearing potential must have a negative pregnancy test at screening.
- A volunteer must be:
- Not of childbearing potential, or
- Of childbearing potential and practicing a highly effective, preferably user independent method of contraception and agrees to remain on a highly effective method while receiving study drug and until 90 days after the last dose of study drug.
- A person of childbearing potential must agree not to donate eggs for the purposes of assisted reproduction during the study and for 90 days after the last dose of study drug.
- During the study and for 90 days after the last dose of study drug, persons who are having sexual relationships in which their partner may become pregnant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person. Persons who are having sexual relationships in which their partner may become pregnant should also be advised of the benefit for their partner to use a highly effective method of contraception as condoms may break or leak.
- +14 more criteria
You may not qualify if:
- History of liver or renal impairment; significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, constipation lasting greater than 2 days), endocrine, neurologic, hematologic, rheumatologic, neoplastic, autoimmune, or metabolic disturbances.
- Known allergies, hypersensitivity, or intolerance to the study drug (JNJ-64281802) or its inactive substances, or an acute, life threatening allergic reaction or swelling following study drug administration.
- History of a severe allergic reaction or anaphylaxis (which is a severe, potentially life-threatening allergic reaction).
- Taken any substances or therapies that are not allowed before the first dose of study drug.
- Received an investigational intervention or participated in another investigational clinical trial (including investigational vaccines) 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. With the exception of participation in COVID-19 vaccine trials and receipt COVID-19 vaccines licensed or under Emergency Use Authorization which can be received at any time.
- Persons of childbearing potential only: Pregnant as determined by a positive pregnancy blood test, breastfeeding, or planning to become pregnant during the study or within 90 days after last dose of study drug.
- Plans to impregnate and help conceive a child during the study or within 90 days after last dose of study drug.
- Any condition for which, in the opinion of the study doctor, participation would not be in the best interest of the participant.
- Blood test confirming current infection with human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2), hepatitis B virus (HBV), or hepatitis C virus (HCV), or blood test confirming past or current infection with any of the following flaviviruses: dengue, Zika virus (ZIKV), West Nile virus, or St. Louis Encephalitis (SLE) virus or vaccination for dengue, Zika virus, or Japanese Encephalitis virus (JEV) Note: Blood laboratory testing will assess the presence of antibodies at screening.
- Recent (in the past 4 weeks) travel to any dengue-endemic region (as defined by the US CDC) or having definite plans to travel to a dengue endemic region, during the study. Potential participants may be eligible for enrollment greater than or equal to 4 weeks after their return from a dengue-endemic region.
- Received or plans to receive:
- Licensed live attenuated vaccines - within 28 days before first dose of study drug until 28 days after last dose of study drug.
- Other licensed (not live) vaccines - within 14 days before first dose of study drug until 14 days after last dose of study drug.
- COVID-19 vaccines, either licensed or under EUA, are allowed at any time during the study however every effort will be made to avoid the above windows of time of administration.
- Note: Vaccinations against DENV and Zika virus are not allowed until 90 days after last dose of study drug.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Janssen, LPcollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (2)
Johns Hopkins University, Bloomberg School of Public Health
Baltimore, Maryland, 21202, United States
University of Vermont Medical Center (UVMMC), Clinical Research Center
Burlington, Vermont, 05401, United States
Related Publications (1)
Durbin AP, Van Wesenbeeck L, Pierce KK, Herrera-Taracena G, Ebone L, Buelens A, Lutton P, Sabundayo BP, Van Eygen V, De Clerck K, Fetter I, Voge NV, Fang X, Goeyvaerts N, Vandendijck Y, Mayfield J, Lenz O, De Meyer S, Kakuda TN, He H, Amaro-Carambot E, Akli RD, Carmolli M, De Marez T, Whitehead SS, Van Loock M, Rasschaert F. Daily Mosnodenvir as Dengue Prophylaxis in a Controlled Human Infection Model. N Engl J Med. 2025 Nov 27;393(21):2107-2118. doi: 10.1056/NEJMoa2500179.
PMID: 41297006DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Anna Durbin
- Organization
- Johns Hopkins School of Public Health Center for Immunization Research
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Durbin, MD
Center for Immunization Research, Johns Hopkins School of Public Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- The subject, investigator, and clinical staff will not know which treatment group the subject has been assigned. In addition, other personnel assigned to monitor the study will not know the treatment assignment of the subject. The pharmacist will be unblinded as the study drug will be provided as bulk supplies.
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2021
First Posted
September 17, 2021
Study Start
February 3, 2022
Primary Completion
May 16, 2023
Study Completion
September 10, 2024
Last Updated
April 24, 2025
Results First Posted
April 24, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share