Trial Outcomes & Findings for An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge (NCT NCT05048875)
NCT ID: NCT05048875
Last Updated: 2025-04-24
Results Overview
Area under the DENV-3 RNA viral load (VL) concentration-time curves from immediately before inoculation (baseline on Day 1) until Day 29. Cohort 2 was recently unblinded (data analysis is in process) and Cohort 2 is not part of the primary outcome assessment. Therefore, it cannot yet be fully represented in the record (i.e., results).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
28 days
Results posted on
2025-04-24
Participant Flow
The study follows an adaptive 2-stage design consisting of 2 cohorts enrolled in a staggered manner. Unblinded interim analysis of Cohort 1 was performed to determine the dosing regimens for Cohort 2 and provided results for the primary outcome. Cohort 2 was recently unblinded (data analysis is in process) and Cohort 2 is not part of the primary outcome assessment. Therefore, it cannot yet be fully represented in the record (i.e., results).
Participant milestones
| Measure |
Cohort 1 - Group 1 JNJ High Dose
JNJ-64281802 (high dose: 600-mg loading dose for 5 days/200-mg maintenance dose for 21 days)
|
Cohort 1 - Group 2 JNJ Medium Dose
JNJ-64281802 (medium dose: 200-mg loading dose for 5 days/50-mg maintenance dose for 21 days)
|
Cohort 1 - Group 2 JNJ Low Dose
JNJ-64281802 (low dose: 40-mg loading dose for 5 days/10-mg maintenance dose for 21 days)
|
Cohort 1 - Group 1/2 Placebo
Placebo (no therapeutic effect). Group 1 Placebo and Group 2 Placebo are combined in one category to be consistent with how data was analyzed. Group 2 placebo were not analyzed on their own (group 1/2 placebos were combined during analysis).
|
Cohort 2 - Group 3 JNJ Daily Dose
JNJ-64281802 800mg-BID for 2 days loading dose followed by 250-mg daily maintenance dose for 21 days)
|
Cohort 2 - Group 4 JNJ Weekly Dose
JNJ-64281802 450mg-BID for 2 days loading dose followed by 1200-mg weekly maintenance dose for 15 days)
|
Cohort 2 - Group 5 JNJ Weekly Dose
JNJ-64281802 250-mg BID for 2 days loading dose followed by 500-mg weekly maintenance dose for 15 days)
|
Cohort 2 - Group 3,4,5 Placebo
Placebo (no therapeutic effect). Group 3, 4, 5 Placebo are combined in one category to be consistent with how data will be analyzed.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
6
|
6
|
8
|
6
|
7
|
6
|
6
|
|
Overall Study
COMPLETED
|
10
|
6
|
6
|
7
|
6
|
7
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 - Group 1 JNJ High Dose
JNJ-64281802 (high dose: 600-mg loading dose for 5 days/200-mg maintenance dose for 21 days)
|
Cohort 1 - Group 2 JNJ Medium Dose
JNJ-64281802 (medium dose: 200-mg loading dose for 5 days/50-mg maintenance dose for 21 days)
|
Cohort 1 - Group 2 JNJ Low Dose
JNJ-64281802 (low dose: 40-mg loading dose for 5 days/10-mg maintenance dose for 21 days)
|
Cohort 1 - Group 1/2 Placebo
Placebo (no therapeutic effect). Group 1 Placebo and Group 2 Placebo are combined in one category to be consistent with how data was analyzed. Group 2 placebo were not analyzed on their own (group 1/2 placebos were combined during analysis).
|
Cohort 2 - Group 3 JNJ Daily Dose
JNJ-64281802 800mg-BID for 2 days loading dose followed by 250-mg daily maintenance dose for 21 days)
|
Cohort 2 - Group 4 JNJ Weekly Dose
JNJ-64281802 450mg-BID for 2 days loading dose followed by 1200-mg weekly maintenance dose for 15 days)
|
Cohort 2 - Group 5 JNJ Weekly Dose
JNJ-64281802 250-mg BID for 2 days loading dose followed by 500-mg weekly maintenance dose for 15 days)
|
Cohort 2 - Group 3,4,5 Placebo
Placebo (no therapeutic effect). Group 3, 4, 5 Placebo are combined in one category to be consistent with how data will be analyzed.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge
Baseline characteristics by cohort
| Measure |
Cohort 1 - Group 1 JNJ High Dose
n=11 Participants
JNJ-64281802 (high dose: 600-mg loading dose for 5 days/200-mg maintenance dose for 21 days).
|
Cohort 1 - Group 2 JNJ Medium Dose
n=6 Participants
JNJ-64281802 (medium dose: 200-mg loading dose for 5 days/50-mg maintenance dose for 21 days)
|
Cohort 1 - Group 2 JNJ Low Dose
n=6 Participants
JNJ-64281802 (low dose: 40-mg loading dose for 5 days/10-mg maintenance dose for 21 days)
|
Cohort 1 - Group 1 and Group 2 Placebo
n=8 Participants
Placebo (no therapeutic effect). Group 1 Placebo and Group 2 Placebo are combined in one category to be consistent with how data was analyzed. Group 2 placebo were not analyzed on their own (group 1/2 placebos were combined during analysis).
|
Cohort 2 - Group 3 JNJ Daily Dose
n=6 Participants
JNJ-64281802 (daily dose: 800-mg BID loading dose for 2 days/250-mg daily maintenance dose for 21 days).
|
Cohort 2 - Gorup 4 JNJ Weekly Dose
n=7 Participants
JNJ-64281802 (weekly dose: 450-mg BID loading dose for 2 days/1200-mg weekly maintenance dose for 15 days).
|
Cohort 2 - Group 5 JNJ Weekly Dose
n=6 Participants
JNJ-64281802 (weekly dose: 250-mg BID loading dose for 2 days/500-mg weekly maintenance dose for 15 days).
|
Cohort 2 - Group 3, Group 4 and Group 5 Placebo
n=6 Participants
Placebo (no therapeutic effect). Group 3 Placebo, Group 4 Placebo and Group 5 Placebo are combined in one category to be consistent with how data will be analyzed.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
56 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
33 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
23 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
53 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
28 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
6 participants
n=21 Participants
|
7 participants
n=10 Participants
|
6 participants
n=115 Participants
|
6 participants
n=6 Participants
|
56 participants
n=6 Participants
|
|
PRNT (50) DENV
PRNT (50) DENV-1 <=10
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
6 participants
n=21 Participants
|
7 participants
n=10 Participants
|
6 participants
n=115 Participants
|
6 participants
n=6 Participants
|
56 participants
n=6 Participants
|
|
PRNT (50) DENV
PRNT (50) DENV-2 <=10
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
6 participants
n=21 Participants
|
7 participants
n=10 Participants
|
6 participants
n=115 Participants
|
6 participants
n=6 Participants
|
56 participants
n=6 Participants
|
|
PRNT (50) DENV
PRNT (50) DENV-3 <=10
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
6 participants
n=21 Participants
|
7 participants
n=10 Participants
|
6 participants
n=115 Participants
|
6 participants
n=6 Participants
|
56 participants
n=6 Participants
|
|
PRNT (50) DENV
PRNT (50) DENV-4 <=10
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
6 participants
n=21 Participants
|
7 participants
n=10 Participants
|
6 participants
n=115 Participants
|
6 participants
n=6 Participants
|
56 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Note group 1 placebo and group 2 placebo are combined per data analysis plan.
Area under the DENV-3 RNA viral load (VL) concentration-time curves from immediately before inoculation (baseline on Day 1) until Day 29. Cohort 2 was recently unblinded (data analysis is in process) and Cohort 2 is not part of the primary outcome assessment. Therefore, it cannot yet be fully represented in the record (i.e., results).
Outcome measures
| Measure |
Cohort 1 Group 1 - JNJ High Dose
n=9 Participants
JNJ-64281802 (high dose: 600-mg loading dose for 5 days/200-mg maintenance dose for 21 days)
|
Cohort 1 Group 2 - JNJ Low Dose
n=6 Participants
JNJ-64281802 (Low dose: 40-mg loading dose for 5 days/10-mg maintenance dose for 21 days)
|
Cohort 1 Group 2 - JNJ Medium Dose
n=6 Participants
JNJ-64281802 (Medium dose: 200-mg loading dose for 5 days/50-mg maintenance dose for 21 days)
|
Cohort 1 Group 1/2 Placebo
n=7 Participants
Placebo (no therapeutic effect)
|
Cohort 2 - Group 3 JNJ Daily Dose
JNJ-64281802 (daily dose: 800-mg BID loading dose for 2 days/250-mg daily maintenance dose for 21 days).
|
Cohort 2 - Group 4 JNJ Weekly Dose
JNJ-64281802 (weekly dose: 450-mg BID loading dose for 2 days/1200-mg weekly maintenance dose for 15 days).
|
Cohort 2 - Group 5 JNJ Weekly Dose
JNJ-64281802 (weekly dose: 250-mg BID loading dose for 2 days/500-mg weekly maintenance dose for 15 days).
|
Cohort 2 - Group 3, Group 4, and Group 5 Placebo
Placebo (no therapeutic effect). Group 3 Placebo, Group 4 Placebo and Group 5 Placebo are combined in one category to be consistent with how data will be analyzed.
|
|---|---|---|---|---|---|---|---|---|
|
Assess the Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo in Terms of Reduction of Dengue Infection.
|
3.00 log10 RNA copies/mL/days
Interval 2.4 to 3.6
|
5.2 log10 RNA copies/mL/days
Interval 4.5 to 5.9
|
4.7 log10 RNA copies/mL/days
Interval 4.0 to 5.4
|
5.0 log10 RNA copies/mL/days
Interval 4.4 to 5.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 85 DaysPopulation: Analysis of Cohort 1 data (Groups 1, 2). Note n=29 (not 31) as 2 subjects were excluded from efficacy analysis due to withdrawal prior to DENV-3 inoculation \[1 subject randomized to placebo w/d due to SAE; 1 subject randomized to high dose group chose to w/d\]. The two subjects who withdrew from the study early are excluded from efficacy analysis but are included in the safety analysis. Also note group 1 placebo and group 2 placebo are combined per sponsor data analysis.
Outcome measures
| Measure |
Cohort 1 Group 1 - JNJ High Dose
n=11 Participants
JNJ-64281802 (high dose: 600-mg loading dose for 5 days/200-mg maintenance dose for 21 days)
|
Cohort 1 Group 2 - JNJ Low Dose
n=6 Participants
JNJ-64281802 (Low dose: 40-mg loading dose for 5 days/10-mg maintenance dose for 21 days)
|
Cohort 1 Group 2 - JNJ Medium Dose
n=6 Participants
JNJ-64281802 (Medium dose: 200-mg loading dose for 5 days/50-mg maintenance dose for 21 days)
|
Cohort 1 Group 1/2 Placebo
n=8 Participants
Placebo (no therapeutic effect)
|
Cohort 2 - Group 3 JNJ Daily Dose
n=6 Participants
JNJ-64281802 (daily dose: 800-mg BID loading dose for 2 days/250-mg daily maintenance dose for 21 days).
|
Cohort 2 - Group 4 JNJ Weekly Dose
n=7 Participants
JNJ-64281802 (weekly dose: 450-mg BID loading dose for 2 days/1200-mg weekly maintenance dose for 15 days).
|
Cohort 2 - Group 5 JNJ Weekly Dose
n=6 Participants
JNJ-64281802 (weekly dose: 250-mg BID loading dose for 2 days/500-mg weekly maintenance dose for 15 days).
|
Cohort 2 - Group 3, Group 4, and Group 5 Placebo
n=6 Participants
Placebo (no therapeutic effect). Group 3 Placebo, Group 4 Placebo and Group 5 Placebo are combined in one category to be consistent with how data will be analyzed.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
Participants with 1 or more serious AE related to inoculation with DENV-3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
Participants with 1 or more serious AE related to study treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
Participants with 1 or more AE (Any AE)
|
11 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
Participants with 1 or more AE related to study treatment
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
Participants with 1 or more AE related to inoculation with DENV-3
|
3 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
Participants with 1 or more AE leading to discontinuation of any study treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
Participants with 1 or more AE leading to termination of study participation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
Participants with 1 or more AE of Mild severity
|
5 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
Participants with 1 or more AE of Moderate severity
|
5 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
Participants with 1 or more AE of Severe severity
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
Participants with 1 or more AE of Life-Threatening severity
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events to Assess the Safety and Tolerability of the Study Drug (JNJ 64281802).
Participants with 1 or more serious AE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksBody temperature will be recorded twice daily by study staff and/or by the participants from Day 1 up to and including Day 29; pulse (bpm), systolic and diastolic blood pressure (mmHg) measured on each clinic visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOccurrence and severity of DENV infection associated AEs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksBlood samples will be taken for measurement of plasma concentrations of JNJ-64281802 at specific time points in the study. Additional PK sampling may be performed on the non-intensive PK days (eg, in the event of an overdose) on other time points, in consultation with the JNJ drug development team. Plasma samples will be analyzed to determine concentrations of JNJ-64281802 using a validated, specific, and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method under the supervision of the DDT's Bioanalytical Laboratory Department of Bioanalysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 99 weeksOutcome measures
Outcome data not reported
Adverse Events
JNJ-64281802 High Dose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo Cohort 1
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
JNJ-64281802 Medium Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
JNJ-64281802 Low Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
JNJ-64281802 Daily Dose (Cohort 2 Group 3)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
JNJ-64281802 Weekly Dose (Cohort 2 Group 4)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
JNJ-64281802 Weekly Dose (Cohort 2 Group 5)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Cohort 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JNJ-64281802 High Dose
n=11 participants at risk
JNJ-64281802 High Dose n=11
|
Placebo Cohort 1
n=8 participants at risk
Placebo Cohort 1 n=8
|
JNJ-64281802 Medium Dose
n=6 participants at risk
JNJ-64281802 Medium dose n=6
|
JNJ-64281802 Low Dose
n=6 participants at risk
JNJ-64281802 Low dose n=6
|
JNJ-64281802 Daily Dose (Cohort 2 Group 3)
n=6 participants at risk
JNJ-64281802 Daily Dose (Cohort 2 Group 3) n=6
|
JNJ-64281802 Weekly Dose (Cohort 2 Group 4)
n=7 participants at risk
JNJ-64281802 Weekly Dose (Cohort 2 Group 4) n=7
|
JNJ-64281802 Weekly Dose (Cohort 2 Group 5)
n=6 participants at risk
JNJ-64281802 Weekly Dose (Cohort 2 Group 5) n=6
|
Placebo Cohort 2
n=6 participants at risk
Placebo Cohort 2 n=6
|
|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Creatinine Kinase High
|
0.00%
0/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
12.5%
1/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Gastrointestinal disorders
AST increased
|
0.00%
0/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
12.5%
1/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Psychiatric disorders
Drug overdose
|
0.00%
0/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
14.3%
1/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
Other adverse events
| Measure |
JNJ-64281802 High Dose
n=11 participants at risk
JNJ-64281802 High Dose n=11
|
Placebo Cohort 1
n=8 participants at risk
Placebo Cohort 1 n=8
|
JNJ-64281802 Medium Dose
n=6 participants at risk
JNJ-64281802 Medium dose n=6
|
JNJ-64281802 Low Dose
n=6 participants at risk
JNJ-64281802 Low dose n=6
|
JNJ-64281802 Daily Dose (Cohort 2 Group 3)
n=6 participants at risk
JNJ-64281802 Daily Dose (Cohort 2 Group 3) n=6
|
JNJ-64281802 Weekly Dose (Cohort 2 Group 4)
n=7 participants at risk
JNJ-64281802 Weekly Dose (Cohort 2 Group 4) n=7
|
JNJ-64281802 Weekly Dose (Cohort 2 Group 5)
n=6 participants at risk
JNJ-64281802 Weekly Dose (Cohort 2 Group 5) n=6
|
Placebo Cohort 2
n=6 participants at risk
Placebo Cohort 2 n=6
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Elevated lipase
|
0.00%
0/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
General disorders
Headache
|
54.5%
6/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
75.0%
6/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
50.0%
3/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
100.0%
6/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
66.7%
4/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
42.9%
3/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
50.0%
3/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
83.3%
5/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
General disorders
Fever
|
0.00%
0/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
12.5%
1/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
14.3%
1/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Infections and infestations
Dengue-like rash
|
27.3%
3/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
87.5%
7/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
66.7%
4/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
83.3%
5/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
14.3%
1/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
66.7%
4/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Investigations
Local Tenderness
|
0.00%
0/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
12.5%
1/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Infections and infestations
Neutropenia
|
0.00%
0/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
12.5%
1/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
33.3%
2/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Infections and infestations
Elevated ALT
|
18.2%
2/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
25.0%
2/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
14.3%
1/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Infections and infestations
Myalgia
|
0.00%
0/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
37.5%
3/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
50.0%
3/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
83.3%
5/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
28.6%
2/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
66.7%
4/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Infections and infestations
Arthalgia
|
9.1%
1/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
25.0%
2/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
33.3%
2/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
14.3%
1/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Infections and infestations
Retroorbital Pain
|
0.00%
0/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
37.5%
3/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
33.3%
2/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
50.0%
3/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
50.0%
3/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
50.0%
3/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Infections and infestations
Fatigue
|
27.3%
3/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
62.5%
5/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
66.7%
4/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
33.3%
2/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
42.9%
3/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
50.0%
3/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
83.3%
5/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Infections and infestations
Nausea
|
36.4%
4/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
50.0%
4/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
66.7%
4/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
28.6%
2/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
33.3%
2/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
33.3%
2/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Investigations
Prolonged PT
|
9.1%
1/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
14.3%
1/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Investigations
Prolonged PTT
|
9.1%
1/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
16.7%
1/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
|
Investigations
Increased Cholesterol
|
18.2%
2/11 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/8 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
33.3%
2/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
33.3%
2/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/7 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
0.00%
0/6 • Adverse event data for cohort 1 was collected for the duration of the enrollment period (90 days total) in relation to baseline. Subjects began the study drug (or placebo) on Day -5 followed by challenge with DENV-3 on Day 1, and were followed for AE's through Day 85.
|
Additional Information
Dr Anna Durbin
Johns Hopkins School of Public Health Center for Immunization Research
Phone: 410-955-1622
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place