Trial Outcomes & Findings for A Study of JNJ-64281802 in Participants With Confirmed Dengue Fever (NCT NCT04906980)

NCT ID: NCT04906980

Last Updated: 2024-03-01

Results Overview

The antiviral activity of JNJ-64281802 versus placebo in terms of reduction of DENV RNA in participants with a primary DENV infection was planned to be measured by the area under the log10-transformed DENV RNA viral load concentration-time curves from baseline (Day 1) until Day 5 (AUCD1-D5 \[log10VL\]).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: Baseline (Day 1) upto Day 5
• Results posted on: 2024-03-01

Participant Flow

Due to small number of enrolled participants, planned data collection and analysis was not performed for the efficacy objectives and no data was reported for efficacy outcome measures and thus only safety analysis data were reported.

Participant milestones

Measure	JNJ-64281802 Participants received 2 initial loading dose of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5.	Placebo Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5.
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of JNJ-64281802 in Participants With Confirmed Dengue Fever

Baseline characteristics by cohort

Measure	JNJ-64281802 n=2 Participants Participants received 2 initial loading dose of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5.	Placebo n=3 Participants Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	47 years STANDARD_DEVIATION 9.9 • n=93 Participants	37.7 years STANDARD_DEVIATION 9.5 • n=4 Participants	41.4 years STANDARD_DEVIATION 9.79 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment SINGAPORE	2 participants n=93 Participants	3 participants n=4 Participants	5 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) upto Day 5

Population: Due to the small number of enrolled participants, planned data collection and analysis was not performed and thus no data was reported for this outcome measure.

The antiviral activity of JNJ-64281802 versus placebo in terms of reduction of DENV RNA in participants with a primary DENV infection was planned to be measured by the area under the log10-transformed DENV RNA viral load concentration-time curves from baseline (Day 1) until Day 5 (AUCD1-D5 [log10VL]).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Day 1 up to the last onsite visit (Day 30)

Population: Safety population included all randomized participants who had taken at least 1 dose of study intervention.

An adverse event (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. TEAEs were those AE events that occurred at or after the initial administration of study intervention through the last onsite visit.

Outcome measures

Measure	JNJ-64281802 n=2 Participants Participants received 2 initial loading dose of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5.	Placebo n=3 Participants Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	2 Participants	3 Participants

SECONDARY outcome

Timeframe: From Day 1 up to the last onsite visit (Day 30)

Population: Safety population included all randomized participants who had taken at least 1 dose of study intervention.

Number of participants with clinically significant abnormalities in ECGs parameters as assessed based on investigator's discretion were reported.

Outcome measures

Measure	JNJ-64281802 n=2 Participants Participants received 2 initial loading dose of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5.	Placebo n=3 Participants Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5.
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 up to the last onsite visit (Day 30)

Population: Safety population included all randomized participants who had taken at least 1 dose of study intervention.

Number of participants with clinically significant abnormalities in physical examination parameters (head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological) as assessed based on investigator's discretion were reported.

Outcome measures

Measure	JNJ-64281802 n=2 Participants Participants received 2 initial loading dose of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5.	Placebo n=3 Participants Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5.
Number of Participants With Clinically Significant Abnormalities in Physical Examination	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 up to the last onsite visit (Day 30)

Population: Safety population included all randomized participants who had taken at least 1 dose of study intervention.

Number of participants with clinically significant abnormalities in vital signs (temperature, pulse/heart rate, respiratory rate, peripheral capillary oxygen saturation [spO2], input-output [I/O] ratio and blood pressure) as assessed based on investigator's discretion were reported.

Outcome measures

Measure	JNJ-64281802 n=2 Participants Participants received 2 initial loading dose of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5.	Placebo n=3 Participants Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5.
Number of Participants With Clinically Significant Abnormalities in Vital Signs	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 up to the last onsite visit (Day 30)

Population: Safety population included all randomized participants who had taken at least 1 dose of study intervention.

Number of participants with clinically significant abnormalities in laboratory parameters (serum chemistry, hematology, and coagulation) were reported. Clinical significance was defined as per investigator's judgement.

Outcome measures

Measure	JNJ-64281802 n=2 Participants Participants received 2 initial loading dose of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5.	Placebo n=3 Participants Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5.
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Predose: 0, 8, 16 hours on Day 1; 24, 32, 40 hours on Day 2; Day 4, Day 5; and Post dose: 4, 12 hours on Day 1; 28, 36 hours on Day 2; 48 hours on Day 3; Day 6, Day 14, Day 21, Day 28

Population: Pharmacokinetic population which included all participants who receive at least 1 dose of study drug and who had at least 1 plasma concentration data value after dosing. Data for this outcome measure was not planned to be collected and analyzed for the placebo arm.

Plasma Concentrations of JNJ-64281802 was assessed. Due to small number of enrolled participants, no summary statistics analysis was performed. Participant wise data were reported for this outcome measure.

Outcome measures

Measure	JNJ-64281802 n=2 Participants Participants received 2 initial loading dose of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5.	Placebo Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5.
Plasma Concentrations of JNJ-64281802 Participant 1: Day 1, pre-dose	5.00 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 1, 4 hr post-dose	1840 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 1, 8 hr pre-dose	2380 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 1, 12 hr post-dose	3210 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 1, 16 hr pre-dose	3530 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 2, 24 hr pre-dose	3300 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 2, 28 hr post-dose	3260 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 2, 32 hr pre-dose	3840 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 2, 36 hr post-dose	4240 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 2, 40 hr pre-dose	4580 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 3, 48 hr post-dose	4880 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 4, pre-dose	3790 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 5, pre-dose	3880 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 6, post-dose	4270 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 14 post-dose	1950 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 21 post dose	1520 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 1: Day 28 post dose	954 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 1, pre-dose	5.00 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 1, 4 hr post-dose	694 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 1, 8 hr pre-dose	819 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 1, 12 hr post-dose	1390 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 1, 16 hr pre-dose	1460 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 2, 24 hr pre-dose	1720 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 2, 28 hr post-dose	2430 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 2, 32 hr pre-dose	2400 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 2, 36 hr post-dose	3710 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 2, 40 hr pre-dose	3960 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 3, 48 hr post-dose	3190 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 4, pre-dose	1780 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 5, pre-dose	2130 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 6, post-dose	2440 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 14 post-dose	1370 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 21 post dose	991 nanograms per milliliter	—
Plasma Concentrations of JNJ-64281802 Participant 2: Day 28 post dose	686 nanograms per milliliter	—

SECONDARY outcome

Timeframe: Predose: 24 hour on Day 2; Post dose: 12 hour on Day 1; 36 hour on Day 2; Days 3, 4, 5, 6, 7, 8, 9, 14, 21 and 28

Population: Due to small number of enrolled participants, planned data collection and analysis was not performed and thus no data was reported for this outcome measure.

Number of participants with occurrence of detectable DENV RNA in primary DENV infection was a planned analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose: 24 hour on Day 2; Post dose: 12 hour on Day 1; 36 hour on Day 2; Days 3, 4, 5, 6, 7, 8, 9, 14, 21 and 28

Population: Due to small number of enrolled participants, planned data collection and analysis was not performed and thus no data was reported for this outcome measure.

Time to undetectable DENV RNA in primary DENV infection was a planned analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 8, 16 hours pre-dose on Day 1; 4 and 12 hours post-dose on Day 1

Population: Due to small number of enrolled participants, formal analysis was not performed for the planned PK parameters and thus no data was reported for this outcome measure

AUC[tau] is defined as area under the plasma concentration time curve during one dosing interval of JNJ-64281802.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose on Day 1: 0 hour, 8 hour, 16 hour; pre-dose on Day 2: 24 hour, 32 hour, 40 hour; pre-dose on Day 4 and Day 5

Population: Due to small number of enrolled participants, formal analysis was not performed for the planned PK parameters and thus no data was reported for this outcome measure.

Ctrough is defined as plasma concentration just prior to the beginning or at the end of a dosing interval of JNJ-64281802.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 8, 16 hours pre-dose on Day 1; 4 and 12 hours post-dose on Day 1

Population: Due to small number of enrolled participants, formal analysis was not performed for the planned PK parameters and thus no data was reported for this outcome measure

Cmax is defined as the maximum observed plasma concentration of JNJ-64281802.

Outcome measures

Outcome data not reported

Adverse Events

JNJ-64281802

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	JNJ-64281802 n=2 participants at risk Participants received 2 initial loading dose of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5.	Placebo n=3 participants at risk Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5.
Blood and lymphatic system disorders Anaemia	50.0% 1/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	0.00% 0/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	66.7% 2/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal Distension	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	66.7% 2/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal Pain	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	50.0% 1/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Gastrointestinal disorders Epigastric Discomfort	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Gastrointestinal disorders Gingival Bleeding	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	66.7% 2/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	50.0% 1/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	100.0% 3/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	66.7% 2/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
General disorders Fatigue	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Infections and infestations Covid-19	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Infections and infestations Influenza	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Infections and infestations Viral Infection	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Injury, poisoning and procedural complications Scratch	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Investigations Aspartate Aminotransferase Increased	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	66.7% 2/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Investigations Lymphocyte Count Decreased	50.0% 1/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	0.00% 0/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Investigations Neutrophil Count Decreased	50.0% 1/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	0.00% 0/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Investigations Platelet Count Decreased	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypokalaemia	50.0% 1/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	0.00% 0/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Back Pain	50.0% 1/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Nervous system disorders Dizziness	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Nervous system disorders Dizziness Postural	50.0% 1/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	0.00% 0/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Pruritus	50.0% 1/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	0.00% 0/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	50.0% 1/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	66.7% 2/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Vascular disorders Flushing	0.00% 0/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	33.3% 1/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
Vascular disorders Hypotension	50.0% 1/2 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.	0.00% 0/3 • From Day 1 up to the last onsite visit (Day 30) Safety population which included all randomized participants who had taken at least 1 dose of study intervention.

Additional Information

GLOBAL MEDICAL LEADER RESPIRATORY INFEC

Janssen Research & Development, LLC

Phone: +12153252489

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER