HealthyPhase 2NCT04480736
A Study of JNJ-64281802 Against Dengue Serotype 1 Infection in a Dengue Human Challenge Model in Healthy Adult Participants
A Phase 2 study testing JNJ-64281802 High dose, JNJ-64281802 Medium dose and JNJ-64281802 Low dose in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-64281802 High dose, JNJ-64281802 Medium dose and JNJ-64281802 Low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2020to 9 Dec 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
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
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
- Being tested
- Placebo, JNJ-64281802 High dose, JNJ-64281802 Medium dose, JNJ-64281802 Low dose, JNJ-64281802 Dosing Regimen X
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching placebo will be administered orally.
JNJ-64281802 High doseDrug
JNJ-64281802 high dose will be administered orally.
JNJ-64281802 Medium doseDrug
JNJ-64281802 medium dose will be administered orally.
JNJ-64281802 Low doseDrug
JNJ-64281802 low dose will be administered orally.
JNJ-64281802 Dosing Regimen XDrug
JNJ-64281802 dosing regimen X will be administered orally.
JNJ-64281802 Dosing Regimen YDrug
JNJ-64281802 dosing regimen Y will be administered orally.
JNJ-64281802 Dosing Regimen ZDrug
JNJ-64281802 dosing regimen Z will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive matching placebo of JNJ-64281802 orally. Receives: Drug: Placebo |
| JNJ-64281802 High dose | Experimental | Participants will receive high dose of JNJ-64281802 orally. Receives: Drug: JNJ-64281802 High dose |
| JNJ-64281802 Medium dose | Experimental | Participants will receive medium dose of JNJ-64281802 orally. Receives: Drug: JNJ-64281802 Medium dose |
| JNJ-64281802 Low dose | Experimental | Participants will receive low dose of JNJ-64281802 orally. Receives: Drug: JNJ-64281802 Low dose |
| JNJ-64281802 Dosing Regimen X | Experimental | Participants will receive dosing regimen X of JNJ-64281802 orally. Receives: Drug: JNJ-64281802 Dosing Regimen X |
| JNJ-64281802 Dosing Regimen Y | Experimental | Participants will receive dosing regimen Y of JNJ-64281802 orally. Receives: Drug: JNJ-64281802 Dosing Regimen Y |
| JNJ-64281802 Dosing Regimen Z | Experimental | Participants will receive dosing regimen Z of JNJ-64281802 orally. Receives: Drug: JNJ-64281802 Dosing Regimen Z |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 29
Secondary outcomes (26)
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.
Measured: Up to Day 85
Number of Participants with Clinically Significant Abnormalities in Physical Examination
Number of participants with clinically significant abnormalities in physical examination will be reported.
Measured: Up to Day 85
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.
Measured: Up to Day 85
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)
Number of participants with clinically significant abnormalities in electrocardiogram (ECGs) will be reported.
Measured: Up to Day 21
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.
Measured: Up to Day 85
Number of Participants with DENV Infection Associated AEs
Number of participants with DENV infection associated AEs will be reported.
Measured: Up to Day 85
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.
Measured: Baseline to Day 29
Peak of Detectable DENV-1 RNA
Peak of detectable DENV-1 RNA will be reported.
Measured: Up to Day 85
Duration of Detectable DENV-1 RNA
Duration of detectable DENV-1 RNA will be reported.
Measured: Up to Day 85
Time to First Onset of Detectable DENV-1 RNA
Time to first onset of detectable DENV-1 RNA will be reported.
Measured: Up to Day 85
Number of Participants with Detectable DENV-1 RNA
Number of participants with detectable DENV-1 RNA will be reported.
Measured: Up to Day 85
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.
Measured: Baseline to Day 29
Area Under the log10-transformed Viremia Curves
Area under the log10-transformed viremia curves will be reported.
Measured: Up to Day 85
Peak of Detectable Viremia Level
Peak of detectable viremia level will be reported.
Measured: Up to Day 85
Duration of Detectable Viremia
Duration of detectable viremia will be reported.
Measured: Up to Day 85
Time to First Onset of Detectable Viremia
Time to first onset of detectable viremia will be reported.
Measured: Up to Day 85
Number of Participants with Detectable Viremia
Number of participants with detectable viremia will be reported.
Measured: Up to Day 85
Maximum Observed Analyte Concentration (Cmax) of JNJ-64281802
Cmax is the maximum observed analyte concentration.
Measured: 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
Minimum Observed Analyte Concentration (Cmin) of JNJ-64281802
Cmin is the minimum observed analyte concentration.
Measured: Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
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.
Measured: Day -4, 1, 6, 8, 10, and 15: Predose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
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.
Measured: 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
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.
Measured: 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
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).
Measured: Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
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.
Measured: 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
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).
Measured: Up to Day 85
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.
Measured: Up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start28 Jul 2020
- Primary completion2 Sep 2027 (estimated)
- Study completion9 Dec 2027 (estimated)
Why it stopped: portfolio reprioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480736
- Sponsor's protocol ID
- CR108700
- Other IDs
- 64281802DNG2001
- Status last verified
- Jan 2025
- First submitted
- 17 Jul 2020
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04480736
- Acronym / sponsor ID
- CR108700
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: portfolio reprioritization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 2 Sep 2027 (estimated)
- Study completion
- 9 Dec 2027 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo of JNJ-64281802 orally. |
| JNJ-64281802 High dose | Experimental | Drug: JNJ-64281802 High doseParticipants will receive high dose of JNJ-64281802 orally. |
| JNJ-64281802 Medium dose | Experimental | Drug: JNJ-64281802 Medium doseParticipants will receive medium dose of JNJ-64281802 orally. |
| JNJ-64281802 Low dose | Experimental | Drug: JNJ-64281802 Low doseParticipants will receive low dose of JNJ-64281802 orally. |
| JNJ-64281802 Dosing Regimen X | Experimental | Drug: JNJ-64281802 Dosing Regimen XParticipants will receive dosing regimen X of JNJ-64281802 orally. |
| JNJ-64281802 Dosing Regimen Y | Experimental | Drug: JNJ-64281802 Dosing Regimen YParticipants will receive dosing regimen Y of JNJ-64281802 orally. |
| JNJ-64281802 Dosing Regimen Z | Experimental | Drug: JNJ-64281802 Dosing Regimen ZParticipants will receive dosing regimen Z of JNJ-64281802 orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMatching placebo will be administered orally. | Drug | Placebo |
| JNJ-64281802 High doseJNJ-64281802 high dose will be administered orally. | Drug | JNJ-64281802 High dose |
| JNJ-64281802 Medium doseJNJ-64281802 medium dose will be administered orally. | Drug | JNJ-64281802 Medium dose |
| JNJ-64281802 Low doseJNJ-64281802 low dose will be administered orally. | Drug | JNJ-64281802 Low dose |
| JNJ-64281802 Dosing Regimen XJNJ-64281802 dosing regimen X will be administered orally. | Drug | JNJ-64281802 Dosing Regimen X |
| JNJ-64281802 Dosing Regimen YJNJ-64281802 dosing regimen Y will be administered orally. | Drug | JNJ-64281802 Dosing Regimen Y |
| JNJ-64281802 Dosing Regimen ZJNJ-64281802 dosing regimen Z will be administered orally. | Drug | JNJ-64281802 Dosing Regimen Z |
Primary outcome
Area Under the DENV-1 RNA VL-concentration time Curve (VL AUC) from Immediately before Inoculation (Baseline on Day 1) until Day 29
Time frame: Baseline to 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.
26 secondary outcomes
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to Day 85
Number of Participants with Clinically Significant Abnormalities in Physical Examination
Time frame: Up to Day 85
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time frame: Up to Day 85
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)
Time frame: Up to Day 21
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Time frame: Up to Day 85
Number of Participants with DENV Infection Associated AEs
Time frame: Up to Day 85
Area Under the log10-transformed DENV 1 RNA VL Concentration-time Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
Time frame: Baseline to Day 29
Peak of Detectable DENV-1 RNA
Time frame: Up to Day 85
Duration of Detectable DENV-1 RNA
Time frame: Up to Day 85
Time to First Onset of Detectable DENV-1 RNA
Time frame: Up to Day 85
Number of Participants with Detectable DENV-1 RNA
Time frame: Up to Day 85
Area Under the Viremia Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
Time frame: Baseline to Day 29
Area Under the log10-transformed Viremia Curves
Time frame: Up to Day 85
Peak of Detectable Viremia Level
Time frame: Up to Day 85
Duration of Detectable Viremia
Time frame: Up to Day 85
Time to First Onset of Detectable Viremia
Time frame: Up to Day 85
Number of Participants with Detectable Viremia
Time frame: Up to Day 85
Maximum Observed Analyte Concentration (Cmax) of JNJ-64281802
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
Minimum Observed Analyte Concentration (Cmin) of JNJ-64281802
Time frame: Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
Trough Plasma Analyte Concentration (Ctrough) of JNJ-64281802
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
Average Analyte Concentration (Cavg) of JNJ-64281802
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
Time to Reach Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-64281802
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
Fluctuation Index (FI) of JNJ-64281802
Time frame: Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau)
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
Number of Participants with Anti DENV-1 Total IgM and IgG Antibody Titers
Time frame: Up to Day 85
Time to First Onset of Anti-DENV-1 Total IgM and IgG Antibody Titers
Time frame: Up to Day 85
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-64281802 High dose, JNJ-64281802 Medium dose and JNJ-64281802 Low dose in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the DENV-1 RNA VL-concentration time Curve (VL AUC) from Immediately before Inoculation (Baseline on Day 1) until Day 29 (time frame: Baseline to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.