Phase 2
N=56
An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge
Dengue
Bottom Line
View on ClinicalTrials.gov: NCT05048875 ↗Enrolled (actual)
56
Serious AEs
3.6%
Results posted
Apr 2025
Primary outcome: Primary: Assess the Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo in Terms of Reduction of Dengue Infection. — 3.00; 5.2; 4.7; 5.0 log10 RNA copies/mL/days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cohort 1 - Group 1 JNJ High Dose (Drug); Cohort 1 - Group 2 JNJ Medium Dose (Drug); Cohort 1 - Group 2 JNJ Low Dose (Drug); Cohort 1 - Group 1/2 Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo in Terms of Reduction of Dengue Infection. |
3.00; 5.2; 4.7; 5.0 | — |
| SECONDARY Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802). |
11; 6; 6; 8; 6; 7 | — |
| SECONDARY Physical Examinations to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802). |
— | — |
| SECONDARY Recording of Vital Signs to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802). |
— | — |
| SECONDARY 12-lead ECG With Measurement of QTcF to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802). |
— | — |
| SECONDARY 12-lead ECG With Measurement of QRS Interval to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802). |
— | — |
| SECONDARY 12-lead ECG With Measurement of PR Interval to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802). |
— | — |
| SECONDARY Clinical Laboratory Assessments to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802). |
— | — |
| SECONDARY Assess the Dengue Infection-associated Adverse Events (Unwanted Medical Occurrence). |
— | — |
| SECONDARY Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo by Reviewing the Area Under the log10-transformed DENV 3 RNA VL Concentration-time Curves From Immediately Before Inoculation (Baseline on Day 1) Until Day 29 (AUCD1 D29 [log10 VL]) |
— | — |
| SECONDARY Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo by Reviewing the Peak of Detectable DENV-3 RNA (log10 VL). |
— | — |
| SECONDARY Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo for Duration in Days of Detectable DENV-3 RNA. |
— | — |
| SECONDARY Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo Time to First Onset by Days of Detectable DENV 3 RNA. |
— | — |
| SECONDARY Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo Based on Presence of Detectable DENV-3 RNA as Measured by PCR (log10 VL) or Culture (log10 VL). |
— | — |
| SECONDARY Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo on Area Under the Infectious Viremia Curves From Immediately Before Inoculation (Baseline on Day 1) Until Day 29. |
— | — |
| SECONDARY Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo on the Area Under the log10-transformed Viremia Curves. |
— | — |
| SECONDARY Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo Peak of Detectable Viremia Level |
— | — |
| SECONDARY Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo on the Duration of Detectable Viremia. |
— | — |
| SECONDARY Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo on Time to First Onset of Detectable Viremia. |
— | — |
| SECONDARY Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo on Presence of Detectable Viremia. |
— | — |
| SECONDARY Assess How the Body Handles the Study Drug (JNJ-64281802) Following Repeated Oral Dosing. Using Pharmacokinetic Analysis From Repeated Blood Samples Taken at Specified Time Points After Drug Administration During 2 Inpatient Stays. |
— | — |
| SECONDARY Cmax: Maximum Observed Analyte Concentration of JNJ-64281802 |
— | — |
| SECONDARY Cmin: Minimum Observed Analyte Concentration of JNJ-64281802 |
— | — |
| SECONDARY Ctrough: Observed Analyte Concentration Just Before the Beginning or at the End of a Dosing Interval of JNJ-64281802 |
— | — |
| SECONDARY Cavg: Average Analyte Concentration Over the Dosing Interval (τ) Calculated as AUCτ/τ of JNJ-64281802 |
— | — |
| SECONDARY Tmax: the Actual Sampling Time to Reach the Maximum Observed Analyte Concentration of JNJ-64281802 |
— | — |
| SECONDARY FI: Percentage Fluctuation (Variation) Between Maximum and Minimum Analyte Concentration at Steady-state, Calculated as 100 x ([Cmax - Cmin] / Cavg) of JNJ-64281802 |
— | — |
| SECONDARY AUCτ: Area Under the Plasma Concentration-time Curve During the Dosing Interval (t Hours); Calculated by Linear-linear Trapezoidal Summation of JNJ-64281802 |
— | — |
| SECONDARY Occurrence and Magnitude of Anti-DENV-3 Total IgM Antibody Titers to Assess the Anti-Dengue Immune Response. |
— | — |
| SECONDARY Occurrence and Magnitude of Anti-DENV-3 Total IgG Antibody Titers to Assess the Anti-Dengue Immune Response. |
— | — |
| SECONDARY Time to First Onset of Anti-DENV-3 Total IgM Antibody Titers to Assess the Anti-Dengue Immune Response. |
— | — |
| SECONDARY Time to First Onset of Anti-DENV-3 Total IgG Antibody Titers to Assess the Anti-Dengue Immune Response. |
— | — |
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.
Eligibility Criteria
Inclusion Criteria for receipt of Study Drug:
- Male or female.
- 18 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.
- A sperm-producing participant must agree not to donate sperm for the purpose of reproduction during the study and for 90 days after the last dose of study drug.
- Must be willing and able to adhere to the study requirements and lifestyle restrictions:
- Do not take any restricted medications/treatments
- Agree to follow all study requirements
- No unusual strenuous exercise
- Must not donate blood or blood products within 6 months after last dose of study drug
- Must not participate in another investigational study during the study or within 90 days after last dose of study drug
- Must not travel to any dengue-endemic region (as defined by the United States Centers for Disease Control and Prevention
- Must limit the use of food or drinks/beverages containing alcohol to the absolute minimum from 48 hours before first dose of study drug until Day 85.
- Must refrain from consumption of grapefruit or grapefruit juice, energy drinks, excessive use of caffeine from 7 days before first dose of study drug until Day 85
- May not use drugs of abuse (including amphetamine, barbiturate, cocaine, methadone, and opiates) until 3 weeks after the last dose of study drug.
- Should not consume any food containing poppy seeds or codeine-containing formulation starting 72 hours before the screening visits and before any visit during the follow-up phase (to avoid a false-positive urine drug test).
- Should follow the instructions for the timing of the standardized meals
- Available for the duration of the study, which is approximately 85 days after injection of the dengue virus.
Exclusion Criteria for receipt of Study Drug:
- History of liver or renal impairme
Data sourced from ClinicalTrials.gov (NCT05048875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.