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| ID | Type | Description | Link |
|---|---|---|---|
| 64281802DNG2004 | Other Identifier | Janssen Research & Development, LLC |
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The study was stopped due to portfolio reprioritization. This decision is not based on any safety concerns.
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The purpose of this study is to evaluate the prophylactic effect of JNJ-64281802 with respect to the prevention of laboratory-confirmed dengue virus (DENV) infection up to the last day of dosing among participants who have no evidence of current DENV infection at baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose JNJ-64281802 regimen (HDR) | Experimental | Participants will receive JNJ-64281802 400 milligrams (mg) loading dose (LD) twice daily for 48 hours (2 days), followed by JNJ-64281802 150 mg maintenance dose (MD) once daily for 26 days in fed conditions. |
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| Low-dose JNJ-64281802 regimen (LDR) | Experimental | Participants will receive JNJ-64281802 150 mg LD twice daily for 48 hours (2 days), followed by JNJ-64281802 50 mg MD once daily for 26 days in fed conditions. |
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| Placebo | Placebo Comparator | Participants will receive JNJ-64281802 matching placebo LD and MD from Day 1 to Day 28. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64281802 | Drug | JNJ-64281802 tablets will be administered orally as per the defined regimens. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Laboratory-confirmed Dengue Virus (DENV) Infection Between Baseline and the Last Day of Dosing + 1 Day Among Household Contacts (HHC) Participants With No Evidence of DENV Infection at Baseline | Number of participants with DENV infection between baseline and the last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Presence of a laboratory-confirmed DENV infection was defined as a positive DENV ribonucleic acid (RNA) (assessed using a validated quantitative DENV reverse transcription polymerase chain reaction [RT-PCR]) or DENV non-structural protein 1 (NS1); assessed by enzyme-linked immunosorbent assay (ELISA) test result. A sample was considered positive for DENV RNA when the result was 'target detected' (when the result was above the limit of detection of the polymerase chain reaction [PCR] assay) or a sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result greater than or equal to [>=] 11 relative units per milliliter [RU/mL]). | Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among All HHC Participants (With or Without Evidence of DENV Infection at Baseline) | Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among all HHC participants (with/without evidence of DENV infection at baseline) were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic adverse events (AEs; retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, rash), lasted for >=1 day and occurred within +/-2 days time window around positive PCR or NS1 test, between baseline and last day of dosing. Sample was considered positive for DENV RNA when result was 'target detected' (when result was above the limit of detection of PCR assay) or sample considered DENV NS1 positive if qualitative DENV NS1 result was positive (quantitative DENV NS1 result >=11 RU/mL). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal De Minas Gerais - Hospital das Clínicas | Belo Horizonte | 31270901 | Brazil | |||
| HUJM - UFMT - Hospital Universitário Júlio Müller - Universidade Federal do Mato Grosso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42253092 | Derived | Bouzidi HS, De Lamballerie X, Touret F. Therapeutic approaches against dengue virus: current status of vaccines, antivirals, and monoclonal antibodies. Emerg Microbes Infect. 2026 Dec;15(1):2686471. doi: 10.1080/22221751.2026.2686471. Epub 2026 Jun 21. |
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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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HHCs included family members, acquaintances, co-workers, and community contacts, who were asymptomatic at screening (no clinical dengue symptoms). For safety assessments, although dosing stopped at Day 28, safety data through Day 50 were included in double-blind (DB) prophylactic phase due to drug's extended half-life (~10 days).
Of 1595 enrolled participants (those who signed informed consent form [ICF]): 616 were index cases, 979 were household contacts (HHCs) identified from index cases. Of 616, 411 met the eligibility criteria for index case population (those who signed ICF and had a laboratory-confirmed dengue infection) and are reported below. Out of 979 HHCs, 128 were screen failures. Per plan, index cases were not included in any analysis and 851 randomized HHCs were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | JNJ-64281802: High Dose Regimen | During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2023 | Jun 25, 2025 |
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| Placebo | Drug | Matching placebo for each dose level as tablet will be administered orally. |
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| Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29) |
| Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among HHC Participants With No Evidence of DENV Infection at Baseline | Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic AEs (retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, and rash), lasted for >=1 day and occurred within a +/-2 days time window around the positive PCR or NS1 test, between baseline and the last day of dosing. A sample was considered positive for DENV RNA when the result was 'target detected' (when result was above the limit of detection of PCR assay) or sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result >=11 RU/mL). | Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts. TEAEs included both serious and non-serious adverse events. | DB prophylactic phase: From start of study treatment (Day 1) up to visit Day 50, considering the long half-life (~10 days) of the study intervention; Follow-up phase: From visit Day 50 up to Day 90 |
| Number of Participants With Treatment-emergent (TE) Worst Grade (Grade 3 or 4) Abnormalities in Vital Signs | Vital signs: pulse and blood pressure (systolic blood pressure[SBP]/diastolic blood pressure[DBP]). Abnormality grades determined per Division of Acquired Immunodeficiency Syndrome (DAIDS) for grading severity of adult and pediatric AEs: SBP(millimeters of mercury[mmHg]):Hypertension:Grade (G)1(mild):141-150, G2(moderate):greater than (>)150-155, G3(severe):>155; SBP(mmHg):Hypotension:G1(mild):85-89, G2(moderate):80 to less than (<)85, G3(severe):<80; DPB(mmHg):Hypertension:G1(mild):91-95, G2(moderate):>95-100, G3(severe):>100; Pulse(beats per minutes[bpm]):Tachycardia: G1(mild):>100-115, G2(moderate):>115-130, G3(severe):>130; Pulse(bpm):Bradycardia:G1(mild):50-54, G2(moderate):<50-45, G3(severe):<45. Any abnormality occurring at/after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered TE. Worst TE toxicity grade=highest grade reached. | From start of drug administration (DB prophylactic Day 1) up to Day 50 |
| Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters | ECG variables: heart rate (HR), PR interval, RR interval, QRS interval, QT interval, and corrected QT (QTc) interval using both following correction methods: QT corrected according to Bazett's formula (QTcB), QT corrected according to Fridericia's formula (QTcF). Abnormalities were categorized as low or high. HR (bpm): low: < 45, high: >=120; PR Interval (milliseconds [ms]): low: <110, high: >=220; QRS interval (ms): high: >=120; QTcB and QTcF (ms): Borderline prolonged QT: 450< QTc <=480, 480 <QTc <=500, QTc >500. Any abnormality occurring at or after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent. | Day 28 |
| Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters | Number of participants with treatment-emergent worst grade (Grade 3 or 4) abnormalities in laboratory parameters were reported. Laboratory assessments included clinical chemistry, hematology and urinalysis. Abnormality criterions were based on DAIDS: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening. Any abnormality occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent. | From start of drug administration (DB prophylactic Day 1) up to Day 50 |
| Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Number of participants with abnormalities in physical examination parameters (head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological) were reported based on investigator's discretion. | Day 50 |
| Plasma Concentrations of JNJ-64281802 | Plasma concentrations of JNJ-64281802 were reported. Plasma samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. | Pre-dose on Day 1; post-dose on Days 3, 5,9, 13, 21, and 28 ; Days 40, 50, and 90 |
| Cuiabá |
| 78055-085 |
| Brazil |
| Hospital e Maternidade Sao Joao de Deus | Laranjeiras do Sul | 49170-000 | Brazil |
| Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado | Manaus | 69040-000 | Brazil |
| Fundacao Universidade Federal de Mato Grosso do Sul | Mato Grosso Do Sul | 79040-010 | Brazil |
| Policlínica Regional Dr Sérgio Arouca | Niterói | 24230-323 | Brazil |
| UPA Unidade de Pronto Atendimento Mário Monteiro | Niterói | 24230-323 | Brazil |
| Instituto de Pesquisas em Patologias Tropicais de Rondônia - IPEPATRO | Porto Velho | 76812-329 | Brazil |
| Centro Bangu - Centro Municipal de Saude Waldyr Franco | Rio de Janeiro | 21040-360 | Brazil |
| Fundacao Oswaldo Cruz Instituto Nacional de Infectologia Evandro Chagas | Rio de Janeiro | 21040-900 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base | São José do Rio Preto | 15090-000 | Brazil |
| CAIMED Acacias | Acacías | Colombia |
| CAIMED Aguazul | Aguazul | 5FH5+44 | Colombia |
| Centro de Reumatologia y Ortopedia | Barranquilla | 080020 | Colombia |
| Hospital Universidad del Norte | Barranquilla | 80020 | Colombia |
| Centre of Care and Diagnosis of the Infectious Diseases (CDI) | Bucaramanga | Colombia |
| Centro de Investigaciones Clinicas S A S | Cali | 760001 | Colombia |
| Programa de Estudio y Control de Enfermedades Tropicales | Medellín | 00000 | Colombia |
| Centro de Atencion e Investigacion Medica S.A. - CAIMED | Yopal - Casanare | 8500001 | Colombia |
| Klinik Kesihatan Kuang | Kuang | 48050 | Malaysia |
| Klinik Kesihatan Pandamaran | Port Klang | 42000 | Malaysia |
| Centro Medico Jojutla | Jojutla | 62900 | Mexico |
| Medical Care & Research SA de CV | Mérida | 97070 | Mexico |
| Unidad de Proyectos Clínicos de Oriente UPCO | Valladolid | CP97780 | Mexico |
| FAICIC S. de R.L. de C.V. | Veracruz | C.P. 91900 | Mexico |
| Cevaxin 24 de diciembre | Cuidad de Panama | Panama |
| Centro de Vacunacion Internacional CEVAXIN Av Mexico | Panama City | Panama |
| Cevaxin La Chorrera | Panama City | Panama |
| INDICASAT Instituto de Investigaciones Científicas y Servicios de Alta Tecnología de Panamá | Panama City | Panama |
| Asociacion Civil Selva Amazonica (ACSA) | Iquitos | 16001 | Peru |
| De La Salle Health Sciences Institute- DLSUMC | Dasmariñas | 4114 | Philippines |
| Las Pinas Doctors Hospital | Las Piñas | 1700 | Philippines |
| Tropical Disease Foundation | Makati | 1230 | Philippines |
| Ponce School of Medicine, Caimed Ctr | Ponce | 00716 | Puerto Rico |
| The Hospital for Tropical Diseases | Bangkok | 10400 | Thailand |
| Songklanagarind hospital | Hat Yai | 90110 | Thailand |
| Srinagarind Hospital | Muang | 40002 | Thailand |
| Research Institute for Health Science, Chiang Mai University | Muang | 50200 | Thailand |
| FG001 | JNJ-64281802: Low Dose Regimen | During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| FG002 | Placebo | During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| FG003 | Index Case Participants | Index case included all enrolled (on Day 1) participants who were with laboratory-confirmed dengue infection and contributed HHC participants. These index case participants were not randomized to receive study intervention. |
| Treated |
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| Participants Who Entered Into Follow-up Phase |
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| COMPLETED |
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| NOT COMPLETED |
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For randomized HHC participants: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. For index case participants: Index case analysis set included all participants enrolled as an index case, with a laboratory-confirmed dengue virus (DENV) infection.
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| ID | Title | Description |
|---|---|---|
| BG000 | JNJ-64281802: High Dose Regimen | During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| BG001 | JNJ-64281802: Low Dose Regimen | During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| BG002 | Placebo | During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| BG003 | Index Case Participants | Index case included all enrolled (on Day 1) participants who were with laboratory-confirmed dengue infection and contributed HHC participants. These index case participants were not randomized to receive study intervention. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Laboratory-confirmed Dengue Virus (DENV) Infection Between Baseline and the Last Day of Dosing + 1 Day Among Household Contacts (HHC) Participants With No Evidence of DENV Infection at Baseline | Number of participants with DENV infection between baseline and the last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Presence of a laboratory-confirmed DENV infection was defined as a positive DENV ribonucleic acid (RNA) (assessed using a validated quantitative DENV reverse transcription polymerase chain reaction [RT-PCR]) or DENV non-structural protein 1 (NS1); assessed by enzyme-linked immunosorbent assay (ELISA) test result. A sample was considered positive for DENV RNA when the result was 'target detected' (when the result was above the limit of detection of the polymerase chain reaction [PCR] assay) or a sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result greater than or equal to [>=] 11 relative units per milliliter [RU/mL]). | Primary analysis set(PAS): all randomized participants who received at least 1 dose of study intervention, who had no evidence of DENV infection at baseline (based on target not detected [TND] results for DENV RNA assay and if available, negative/borderline result for NS1 protein assays) and with at least 1 result for DENV RNA or NS1 protein assay available post baseline up to and including last day of dosing + 1 day. As pre-planned, data collection and analysis was not performed for index case. | Posted | Count of Participants | Participants | Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29) |
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| Secondary | Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among All HHC Participants (With or Without Evidence of DENV Infection at Baseline) | Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among all HHC participants (with/without evidence of DENV infection at baseline) were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic adverse events (AEs; retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, rash), lasted for >=1 day and occurred within +/-2 days time window around positive PCR or NS1 test, between baseline and last day of dosing. Sample was considered positive for DENV RNA when result was 'target detected' (when result was above the limit of detection of PCR assay) or sample considered DENV NS1 positive if qualitative DENV NS1 result was positive (quantitative DENV NS1 result >=11 RU/mL). | Complete analysis set: All participants included in PAS or secondary analysis set (SAS) (all randomized participants who received at least 1 dose of study intervention, had evidence of DENV infection [based on positive results for DENV RNA or NS1 protein assays at baseline] but without DENV signs and symptoms at baseline). As pre-planned, data collection and analysis was not performed for index case. | Posted | Count of Participants | Participants | Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29) |
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| Secondary | Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among HHC Participants With No Evidence of DENV Infection at Baseline | Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic AEs (retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, and rash), lasted for >=1 day and occurred within a +/-2 days time window around the positive PCR or NS1 test, between baseline and the last day of dosing. A sample was considered positive for DENV RNA when the result was 'target detected' (when result was above the limit of detection of PCR assay) or sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result >=11 RU/mL). | PAS included all randomized participants who received at least 1 dose of study intervention, who had no evidence of DENV infection at baseline (based on TND] results for DENV RNA assay and, if available, a negative/borderline result for NS1 protein assays) and with at least 1 result for DENV RNA or NS1 protein assay available post baseline up to and including the last day of dosing + 1 day. As pre-planned, data collection and analysis was not performed for index case. | Posted | Count of Participants | Participants | Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29) |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts. TEAEs included both serious and non-serious adverse events. | Safety analysis set included all randomized participants who received at least 1 dose of study intervention. As pre-planned, data collection and analysis was not performed for index case. | Posted | Count of Participants | Participants | DB prophylactic phase: From start of study treatment (Day 1) up to visit Day 50, considering the long half-life (~10 days) of the study intervention; Follow-up phase: From visit Day 50 up to Day 90 |
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| Secondary | Number of Participants With Treatment-emergent (TE) Worst Grade (Grade 3 or 4) Abnormalities in Vital Signs | Vital signs: pulse and blood pressure (systolic blood pressure[SBP]/diastolic blood pressure[DBP]). Abnormality grades determined per Division of Acquired Immunodeficiency Syndrome (DAIDS) for grading severity of adult and pediatric AEs: SBP(millimeters of mercury[mmHg]):Hypertension:Grade (G)1(mild):141-150, G2(moderate):greater than (>)150-155, G3(severe):>155; SBP(mmHg):Hypotension:G1(mild):85-89, G2(moderate):80 to less than (<)85, G3(severe):<80; DPB(mmHg):Hypertension:G1(mild):91-95, G2(moderate):>95-100, G3(severe):>100; Pulse(beats per minutes[bpm]):Tachycardia: G1(mild):>100-115, G2(moderate):>115-130, G3(severe):>130; Pulse(bpm):Bradycardia:G1(mild):50-54, G2(moderate):<50-45, G3(severe):<45. Any abnormality occurring at/after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered TE. Worst TE toxicity grade=highest grade reached. | Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. Only parameter (SBP: Hypertension) in which at least 1 participant had data was reported. As pre-planned, data collection and analysis was not performed for index case. | Posted | Count of Participants | Participants | From start of drug administration (DB prophylactic Day 1) up to Day 50 |
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| Secondary | Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters | ECG variables: heart rate (HR), PR interval, RR interval, QRS interval, QT interval, and corrected QT (QTc) interval using both following correction methods: QT corrected according to Bazett's formula (QTcB), QT corrected according to Fridericia's formula (QTcF). Abnormalities were categorized as low or high. HR (bpm): low: < 45, high: >=120; PR Interval (milliseconds [ms]): low: <110, high: >=220; QRS interval (ms): high: >=120; QTcB and QTcF (ms): Borderline prolonged QT: 450< QTc <=480, 480 <QTc <=500, QTc >500. Any abnormality occurring at or after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent. | Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants analyzed at specified rows. Only those parameters in which at least 1 participant had data was reported in this outcome measure. As pre-planned, data collection and analysis was not performed for index case. | Posted | Count of Participants | Participants | Day 28 |
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| Secondary | Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters | Number of participants with treatment-emergent worst grade (Grade 3 or 4) abnormalities in laboratory parameters were reported. Laboratory assessments included clinical chemistry, hematology and urinalysis. Abnormality criterions were based on DAIDS: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening. Any abnormality occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent. | Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants analyzed at specified rows. Only those parameters in which at least 1 participant had data was reported in this outcome measure. As pre-planned, data collection and analysis was not performed for index case. | Posted | Count of Participants | Participants | From start of drug administration (DB prophylactic Day 1) up to Day 50 |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Number of participants with abnormalities in physical examination parameters (head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological) were reported based on investigator's discretion. | Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. As pre-planned, data collection and analysis was not performed for index case. | Posted | Count of Participants | Participants | Day 50 |
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| Secondary | Plasma Concentrations of JNJ-64281802 | Plasma concentrations of JNJ-64281802 were reported. Plasma samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. | Pharmacokinetic analysis set included all participants who received at least 1 dose of study intervention and who had at least 1 plasma concentration data value after dosing. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure, 'n' (number analyzed) refers to all participants evaluable at specified time points. Data for this outcome measure was planned to be collected and analyzed for specified arms only. | Posted | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | Pre-dose on Day 1; post-dose on Days 3, 5,9, 13, 21, and 28 ; Days 40, 50, and 90 |
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All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (~10 days).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DB Prophylactic Phase: JNJ-64281802: High Dose Regimen | During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (~10 days) of the study intervention. | 1 | 283 | 3 | 282 | 107 | 282 |
| EG001 | DB Prophylactic Phase: JNJ-64281802: Low Dose Regimen | During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (~10 days) of the study intervention. | 0 | 283 | 0 | 281 | 106 | 281 |
| EG002 | DB Prophylactic Phase: Placebo | During the DB prophylactic dosing phase, HHC participants received placebo (matching JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (~10 days) of the study intervention. | 0 | 285 | 1 | 284 | 109 | 284 |
| EG003 | Follow-up Phase: JNJ-64281802: High Dose Regimen | After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial). | 0 | 69 | 0 | 69 | 9 | 69 |
| EG004 | Follow-up Phase: JNJ-64281802: Low Dose Regimen | After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial). | 0 | 68 | 0 | 68 | 6 | 68 |
| EG005 | Follow-up Phase: Placebo | After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial). | 0 | 69 | 0 | 69 | 8 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Unstable | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Hypertensive Heart Disease | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Cholecystitis Acute | Hepatobiliary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Crush Injury | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Leader | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 21, 2024 | Jun 25, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
Not provided
Not provided
| Male |
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| Undifferentiated |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Colombia |
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| Mexico |
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| Panama |
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| Philippines |
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| Thailand |
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| Peru |
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| Superiority |
| The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed. | Exact logistic regression model | P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia). | =0.1418 | One-sided p-value | Odds Ratio (OR) | 67.2 | 1-Sided | 80 | 14.9 | 1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia). | Superiority |
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| OG001 | JNJ-64281802: Low Dose Regimen | During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| OG002 | Placebo | During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
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| JNJ-64281802: High Dose Regimen |
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| OG001 | JNJ-64281802: Low Dose Regimen | During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| OG002 | Placebo | During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
|
|
|
| OG001 | DB Prophylactic Phase: JNJ-64281802: Low Dose Regimen | During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (~10 days) of the study intervention. |
| OG002 | DB Prophylactic Phase: Placebo | During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (~10 days) of the study intervention. |
| OG003 | Follow-up Phase: JNJ-64281802: High Dose Regimen | After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| OG004 | Follow-up Phase: JNJ-64281802: Low Dose Regimen | After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| OG005 | Follow-up Phase: Placebo | After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial). |
|
|
| OG001 | JNJ-64281802: Low Dose Regimen | During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| OG002 | Placebo | During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
|
|
| OG001 | JNJ-64281802: Low Dose Regimen | During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| OG002 | Placebo | During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
|
|
| OG001 | JNJ-64281802: Low Dose Regimen | During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
| OG002 | Placebo | During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
|
|
| OG002 | Placebo | During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial). |
|
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During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
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