Trial Outcomes & Findings for A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model (NCT NCT06170242)
NCT ID: NCT06170242
Last Updated: 2025-10-07
Results Overview
Measured by qRT-PCR in nasal samples.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
Day 1 to Day 12
Results posted on
2025-10-07
Participant Flow
A total of 142 participants were enrolled and inoculated with challenge virus (Respiratory Syncytial Virus \[RSV\]-A Memphis 37b) of which 141 participants were randomized 1:1:1 into one of three treatment groups to receive EDP-323 (at two different doses) or placebo at one site in the United Kingdom between November 2023 and July 2024.
One participant was enrolled and received RSV-A Memphis 37b virus inoculation on Day 0 but was not randomized to receive EDP-323 or matched placebo.
Participant milestones
| Measure |
EDP-323 High Dose
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 once daily (QD) for 5 days.
|
EDP-323 Low Dose
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
Enrolled But Not Randomized
Participant received RSV-A Memphis 37b virus inoculation on Day 0 but was not randomized to receive EDP-323 or matched placebo.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
47
|
1
|
|
Overall Study
COMPLETED
|
47
|
47
|
46
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
EDP-323 High Dose
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 once daily (QD) for 5 days.
|
EDP-323 Low Dose
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
Enrolled But Not Randomized
Participant received RSV-A Memphis 37b virus inoculation on Day 0 but was not randomized to receive EDP-323 or matched placebo.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model
Baseline characteristics by cohort
| Measure |
EDP-323 High Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.09 years
STANDARD_DEVIATION 6.372 • n=5 Participants
|
27.62 years
STANDARD_DEVIATION 5.980 • n=7 Participants
|
27.91 years
STANDARD_DEVIATION 6.223 • n=5 Participants
|
28.21 years
STANDARD_DEVIATION 6.182 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 12Population: Intent-to-treat infected (ITT-I) Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection.
Measured by qRT-PCR in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=26 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=30 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR): RSV Area Under the Viral Load-time Curve (VL-AUC)
|
99.05 log10 copies/mL*hours
Standard Deviation 133.325
|
82.28 log10 copies/mL*hours
Standard Deviation 158.033
|
657.45 log10 copies/mL*hours
Standard Deviation 396.743
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection.
Measured by qRT-PCR in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=26 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=30 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
qRT-PCR: RSV Peak Viral Load (VLPEAK)
|
2.52 log10 copies/mL
Standard Deviation 2.173
|
1.99 log10 copies/mL
Standard Deviation 2.711
|
6.48 log10 copies/mL
Standard Deviation 2.311
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection.
Measured by qRT-PCR in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=26 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=30 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to RSV VLPEAK
|
2.89 days
Standard Deviation 2.922
|
3.12 days
Standard Deviation 3.113
|
3.12 days
Standard Deviation 1.555
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with available data.
The time from the assessment at the time of the first dose of IMP to qRT-viral load negativity was analyzed using the Kaplan-Meier method. Viral load negativity was reached at the first time when the viral load was undetectable (\< lower limit of detection \[LLOD\]) by qRT-PCR, after which no further detectable assessment appeared. Measured by qRT-PCR in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=20 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=17 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=30 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to RSV Viral Load Negativity
|
2.3 days
Interval 1.0 to 6.5
|
1.5 days
Interval 0.5 to 6.0
|
8.5 days
Interval 6.5 to
Upper confidence interval was not reached due to lack of events and the upper bound extending beyond the largest observed time for this group.
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with at least one detectable viral load during qRT-PCR.
Time to first negative slope = time of the timepoint after which there are two consecutive declines in viral load - time of the nearest viral load assessment to the first dose of IMP. Measured by qRT-PCR in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=13 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=9 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=27 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to First Negative Slope of RSV Viral Load
|
0.77 days
Standard Deviation 0.954
|
1.33 days
Standard Deviation 2.360
|
2.60 days
Standard Deviation 1.632
|
SECONDARY outcome
Timeframe: Up to Day 16Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with at least one detectable viral load during qRT-PCR.
Calculated as the slope of the RSV viral load over time from time of RSV VLPEAK to 1, 2, 3, and 4 days later. Estimates for fixed effects of a mixed linear model, modeling the viral load from peak up to the 4 following days, with time from VLPEAK, group and interaction between time and group as fixed effects and a random intercept within each participant. The model was a distinct analysis for the EDP-323 high dose and placebo groups where the estimates for both groups are model-dependent and impacted by the overall model. A negative slope indicated that the viral load decreased over time. Measured by qRT-PCR in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=17 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=28 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
qRT-PCR: RSV Viral Load Clearance Rate - EDP-323 High Dose
|
-0.5650 log10 copies/mL/day
Interval -0.7539 to -0.3761
|
-1.3299 log10 copies/mL/day
Interval -1.4775 to -1.1823
|
—
|
SECONDARY outcome
Timeframe: Up to Day 16Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with at least one detectable viral load during qRT-PCR.
Calculated as the slope of the RSV viral load over time from time of RSV VLPEAK to 1, 2, 3, and 4 days later. Estimates for fixed effects of a mixed linear model, modeling the viral load from peak up to the 4 following days, with time from VLPEAK, group and interaction between time and group as fixed effects and a random intercept within each participant. The model was a distinct analysis for the EDP-323 low dose and placebo groups where the estimates for both groups are model-dependent and impacted by the overall model. A negative slope indicated that the viral load decreased over time. Measured by qRT-PCR in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=10 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=28 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
qRT-PCR: RSV Viral Load Clearance Rate - EDP-323 Low Dose
|
-0.5480 log10 copies/mL/day
Interval -0.8182 to -0.2778
|
-1.3298 log10 copies/mL/day
Interval -1.4896 to -1.1699
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection.
Measured by viral culture (plaque assay) in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=26 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=30 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Viral Culture: RSV VL-AUC
|
3.82 log10 plaque-forming units (PFU)/mL*h
Standard Deviation 9.333
|
6.21 log10 plaque-forming units (PFU)/mL*h
Standard Deviation 15.448
|
227.04 log10 plaque-forming units (PFU)/mL*h
Standard Deviation 189.998
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection.
Measured by viral culture (plaque assay) in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=26 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=30 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Viral Culture: RSV VLPEAK
|
0.04 log10 PFU/mL
Standard Deviation 0.198
|
0.16 log10 PFU/mL
Standard Deviation 0.569
|
3.45 log10 PFU/mL
Standard Deviation 2.191
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection.
Measured by viral culture (plaque assay) in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=26 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=30 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Viral Culture: Time From the Assessment at the Time of the First Dose of IMP to RSV VLPEAK
|
5.82 days
Standard Deviation 2.980
|
5.78 days
Standard Deviation 3.304
|
3.95 days
Standard Deviation 2.290
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with available data.
Measured by viral culture (plaque assay) in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=6 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=6 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Viral Culture: Time From the Assessment at the Time of the First Dose of IMP to RSV Viral Load Negativity
|
0.5 days
Interval 0.5 to
Upper confidence interval was not reached due to lack of events.
|
0.5 days
Interval 0.5 to
Upper confidence interval was not reached due to lack of events.
|
4.5 days
Interval 4.5 to 5.5
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with at least one detectable viral load during plaque assay.
Measured by viral culture (plaque assay) in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=3 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=3 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Viral Culture: Time From the Assessment at the Time of the First Dose of IMP to First Negative Slope of RSV Viral Load
|
0.00 days
Standard Deviation 0.000
|
0.00 days
Standard Deviation 0.000
|
2.92 days
Standard Deviation 1.739
|
SECONDARY outcome
Timeframe: Up to Day 16Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with at least one detectable viral load during plaque assay.
Calculated as the slope of the RSV viral load over time from time of RSV VLPEAK to 1, 2, 3, and 4 days later. Estimates for fixed effects of a mixed linear model, modeling the viral load from peak up to the 4 following days, with time from VLPEAK, group and interaction between time and group as fixed effects and a random intercept within each participant. A negative slope indicated that the viral load decreased over time. Measured by viral culture in nasal samples.
Outcome measures
| Measure |
EDP-323 High Dose
n=3 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=3 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Viral Culture: RSV Viral Load Clearance Rate
|
-0.1336 log10 PFU/mL/day
Interval -0.7642 to 0.497
|
-0.2565 log10 PFU/mL/day
Interval -0.699 to 0.1861
|
-1.1124 log10 PFU/mL/day
Interval -1.2522 to -0.9727
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection.
An individual TSS (10-items) was derived at each assessment of the diary card as the sum of the scores given to the 10 following symptoms on that symptom score card, giving a score between 0 and 3: * Runny nose * Stuffy nose * Sneezing * Sore throat * Earache * Malaise/Tiredness * Headache * Muscle and/or Joint Ache * Cough * Shortness of breath TSS ranged from 0 to 30 with higher TSS indicating a higher disease burden and thus a worse outcome. The calculation of the TSS-AUC was performed on the TSS measured 3 times a day using the trapezoidal summation rule based on actual time intervals in hours.
Outcome measures
| Measure |
EDP-323 High Dose
n=26 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=30 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Area Under the Total Symptom Score (TSS)-Time Curve (TSS-AUC)
|
127.31 score*hours
Standard Deviation 149.221
|
82.67 score*hours
Standard Deviation 100.412
|
369.10 score*hours
Standard Deviation 330.397
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection.
Defined as the highest recorded value of TSS. An individual TSS (10-items) was derived at each assessment of the diary card as the sum of the scores given to the 10 following symptoms on that symptom score card, giving a score between 0 and 3: * Runny nose * Stuffy nose * Sneezing * Sore throat * Earache * Malaise/Tiredness * Headache * Muscle and/or Joint Ache * Cough * Shortness of breath TSS ranged from 0 to 30 with higher TSS indicating a higher disease burden and thus a worse outcome.
Outcome measures
| Measure |
EDP-323 High Dose
n=26 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=30 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Peak TSS
|
2.65 score on a scale
Standard Deviation 1.765
|
2.35 score on a scale
Standard Deviation 2.673
|
5.77 score on a scale
Standard Deviation 4.439
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection.
Time to peak TSS = time of peak TSS - time of the nearest TSS assessment to the first dose of IMP. An individual TSS (10-items) was derived at each assessment of the diary card as the sum of the scores given to the 10 following symptoms on that symptom score card, giving a score between 0 and 3: * Runny nose * Stuffy nose * Sneezing * Sore throat * Earache * Malaise/Tiredness * Headache * Muscle and/or Joint Ache * Cough * Shortness of breath TSS ranged from 0 to 30 with higher TSS indicating a higher disease burden and thus a worse outcome.
Outcome measures
| Measure |
EDP-323 High Dose
n=26 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=30 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Time to Peak TSS
|
2.00 days
Standard Deviation 2.403
|
2.84 days
Standard Deviation 3.125
|
3.36 days
Standard Deviation 2.065
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive of participants with at least one TSS \>0 only.
Time to resolution from peak TSS = time of the first 24-hour symptom-free time point - time of peak TSS. An individual TSS (10-items) was derived at each assessment of the diary card as the sum of the scores given to the 10 following symptoms on that symptom score card, giving a score between 0 and 3: * Runny nose * Stuffy nose * Sneezing * Sore throat * Earache * Malaise/Tiredness * Headache * Muscle and/or Joint Ache * Cough * Shortness of breath TSS ranged from 0 to 30 with higher TSS indicating a higher disease burden and thus a worse outcome.
Outcome measures
| Measure |
EDP-323 High Dose
n=24 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=16 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=28 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Time to Resolution From Peak TSS
|
2.16 days
Standard Deviation 1.922
|
2.58 days
Standard Deviation 2.415
|
2.93 days
Standard Deviation 1.789
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with available data.
Each participant was given pre-weighed packets of paper tissues. Participants were asked to place single tissues used for nose blowing or sneezing into a specified collection bag (for that participant only).
Outcome measures
| Measure |
EDP-323 High Dose
n=26 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=29 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Total Weight of Nasal Discharge (Mucus) Produced
|
6.12 grams
Standard Deviation 6.564
|
9.49 grams
Standard Deviation 20.537
|
16.44 grams
Standard Deviation 22.152
|
SECONDARY outcome
Timeframe: Day 1 to Day 12Population: ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with available data.
Each participant was given pre-weighed packets of paper tissues. Participants were asked to place single tissues used for nose blowing or sneezing into a specified collection bag (for that participant only).
Outcome measures
| Measure |
EDP-323 High Dose
n=26 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=23 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=29 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Total Number of Tissues Used
|
17.62 tissues
Standard Deviation 23.329
|
16.22 tissues
Standard Deviation 21.457
|
28.79 tissues
Standard Deviation 27.580
|
SECONDARY outcome
Timeframe: First Dose: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose) and Day 2 pre-dose; Last Dose: Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose)Population: PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint.
Plasma pharmacokinetic (PK) parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The plasma PK parameters were estimated from the concentration-time profiles. In estimating the PK parameters, below the limit of quantification (BQL) values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by \>20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table.
Outcome measures
| Measure |
EDP-323 High Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
Last Dose: EP-038725
|
1294.19 ng/mL
Standard Deviation 772.921
|
381.94 ng/mL
Standard Deviation 266.839
|
—
|
|
Maximum Plasma Concentration (Cmax)
First Dose: EDP-323
|
1358.47 ng/mL
Standard Deviation 590.191
|
1453.70 ng/mL
Standard Deviation 627.552
|
—
|
|
Maximum Plasma Concentration (Cmax)
Last Dose: EDP-323
|
1703.09 ng/mL
Standard Deviation 746.730
|
759.38 ng/mL
Standard Deviation 322.938
|
—
|
|
Maximum Plasma Concentration (Cmax)
First Dose: EP-038725
|
1225.02 ng/mL
Standard Deviation 753.882
|
1501.55 ng/mL
Standard Deviation 776.020
|
—
|
|
Maximum Plasma Concentration (Cmax)
First Dose: EP-039082
|
5.40 ng/mL
Standard Deviation 5.265
|
6.59 ng/mL
Standard Deviation 4.923
|
—
|
|
Maximum Plasma Concentration (Cmax)
Last Dose: EP-039082
|
6.41 ng/mL
Standard Deviation 5.131
|
1.40 ng/mL
Standard Deviation 1.346
|
—
|
SECONDARY outcome
Timeframe: First Dose: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose) and Day 2 pre-dose; Last Dose: Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose)Population: PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint.
Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The plasma PK parameters were estimated from the concentration-time profiles. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by \>20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table.
Outcome measures
| Measure |
EDP-323 High Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Time to Cmax (Tmax)
Last Dose: EP-039082
|
3.82 hours
Interval 1.0 to 9.9
|
2.00 hours
Interval 0.0 to 7.9
|
—
|
|
Time to Cmax (Tmax)
First Dose: EDP-323
|
3.98 hours
Interval 1.0 to 10.2
|
3.92 hours
Interval 1.9 to 9.9
|
—
|
|
Time to Cmax (Tmax)
Last Dose: EDP-323
|
4.82 hours
Interval 2.0 to 9.9
|
4.10 hours
Interval 1.0 to 10.3
|
—
|
|
Time to Cmax (Tmax)
First Dose: EP-038725
|
3.97 hours
Interval 1.9 to 10.2
|
3.85 hours
Interval 1.9 to 9.9
|
—
|
|
Time to Cmax (Tmax)
Last Dose: EP-038725
|
4.92 hours
Interval 2.0 to 9.9
|
3.98 hours
Interval 1.0 to 10.0
|
—
|
|
Time to Cmax (Tmax)
First Dose: EP-039082
|
3.00 hours
Interval 0.0 to 9.9
|
2.97 hours
Interval 0.9 to 9.9
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose), Day 2 pre-dose, Day 3 pre-dose, Day 4 pre-dose, Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose)Population: PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. No participants in the EDP-323 low dose group had quantifiable samples for EP-039082 (below limit of quantification \[BLQ\]) for the analysis of this PK parameter.
Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The plasma PK parameters were estimated from the concentration-time profiles. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by \>20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table.
Outcome measures
| Measure |
EDP-323 High Dose
n=46 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=46 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Terminal Half-life (t1/2)
EP-038725
|
16.56 hours
Standard Deviation 3.049
|
17.16 hours
Standard Deviation 3.103
|
—
|
|
Terminal Half-life (t1/2)
EDP-323
|
13.07 hours
Standard Deviation 4.793
|
12.55 hours
Standard Deviation 4.621
|
—
|
|
Terminal Half-life (t1/2)
EP-039082
|
3.89 hours
Standard Deviation 1.346
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose), Day 2 pre-dose, Day 3 pre-dose, Day 4 pre-dose, Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose)Population: PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. No participants in the EDP-323 high dose and EDP-323 low dose groups had quantifiable samples for EP-038725 and EP-039082 (BLQ) for the analysis of this PK parameter.
Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The plasma PK parameters were estimated from the concentration-time profiles. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by \>20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table.
Outcome measures
| Measure |
EDP-323 High Dose
n=46 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=46 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Apparent Systemic Clearance at Steady-state (CLss/F)
EDP-323
|
32.39 L/h
Standard Deviation 13.648
|
24.51 L/h
Standard Deviation 11.383
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose), Day 2 pre-dose, Day 3 pre-dose, Day 4 pre-dose, Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose)Population: PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. No participants in the EDP-323 low dose group had quantifiable samples for EP-039082 (BLQ) for the analysis of this PK parameter.
Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The plasma PK parameters were estimated from the concentration-time profiles. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by \>20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table.
Outcome measures
| Measure |
EDP-323 High Dose
n=46 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=46 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Terminal Elimination Rate Constant (λz)
EP-038725
|
0.04 per hour
Standard Deviation 0.009
|
0.04 per hour
Standard Deviation 0.008
|
—
|
|
Terminal Elimination Rate Constant (λz)
EDP-323
|
0.06 per hour
Standard Deviation 0.018
|
0.06 per hour
Standard Deviation 0.019
|
—
|
|
Terminal Elimination Rate Constant (λz)
EP-039082
|
0.17 per hour
Standard Deviation 0.061
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose), Day 2 pre-dose, Day 3 pre-dose, Day 4 pre-dose, Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose)Population: PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. No participants in the EDP-323 high dose and EDP-323 low dose groups had quantifiable samples for EP-038725 and EP-039082 (BLQ) for the analysis of this PK parameter.
Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The plasma PK parameters were estimated from the concentration-time profiles. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by \>20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table.
Outcome measures
| Measure |
EDP-323 High Dose
n=46 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=46 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Apparent Volume of Distribution at Steady-state (Vss/F)
EDP-323
|
569.26 liters
Standard Deviation 208.202
|
402.73 liters
Standard Deviation 143.305
|
—
|
SECONDARY outcome
Timeframe: First Dose: Day 1, 12 and 24 hours post-dose; Last Dose: Day 5, 12 and 24 hours post-dosePopulation: PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint.
In case of an actual sampling time deviating by \>20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table.
Outcome measures
| Measure |
EDP-323 High Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)
First Dose C24h: EDP-323
|
351.45 ng/mL
Standard Deviation 166.086
|
368.54 ng/mL
Standard Deviation 216.140
|
—
|
|
Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)
Last Dose C12h: EDP-323
|
935.04 ng/mL
Standard Deviation 318.005
|
423.38 ng/mL
Standard Deviation 203.294
|
—
|
|
Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)
Last Dose C12h: EP-039082
|
1.60 ng/mL
Standard Deviation 0.739
|
1.00 ng/mL
Standard Deviation 0.014
|
—
|
|
Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)
Last Dose C24h: EDP-323
|
493.16 ng/mL
Standard Deviation 250.229
|
220.69 ng/mL
Standard Deviation 141.715
|
—
|
|
Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)
First Dose C12h: EDP-323
|
711.96 ng/mL
Standard Deviation 265.557
|
756.02 ng/mL
Standard Deviation 345.633
|
—
|
|
Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)
First Dose C12h: EP-038725
|
189.71 ng/mL
Standard Deviation 94.962
|
221.48 ng/mL
Standard Deviation 162.256
|
—
|
|
Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)
First Dose C24h: EP-038725
|
52.47 ng/mL
Standard Deviation 27.362
|
56.57 ng/mL
Standard Deviation 23.845
|
—
|
|
Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)
Last Dose C12h: EP-038725
|
281.01 ng/mL
Standard Deviation 168.564
|
78.22 ng/mL
Standard Deviation 39.056
|
—
|
|
Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)
Last Dose C24h: EP-038725
|
96.78 ng/mL
Standard Deviation 59.546
|
30.29 ng/mL
Standard Deviation 14.620
|
—
|
|
Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)
First Dose C12h: EP-039082
|
1.28 ng/mL
Standard Deviation 0.493
|
1.44 ng/mL
Standard Deviation 0.775
|
—
|
|
Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)
First Dose C24h: EP-039082
|
1.00 ng/mL
Standard Deviation 0.000
|
1.01 ng/mL
Standard Deviation 0.041
|
—
|
|
Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)
Last Dose C24h: EP-039082
|
1.04 ng/mL
Standard Deviation 0.166
|
1.00 ng/mL
Standard Deviation 0.000
|
—
|
SECONDARY outcome
Timeframe: First Dose: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose) and Day 2 pre-dose; Last Dose: Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose)Population: PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint.
Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The AUCs were calculated using linear up/log down method. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by \>20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table.
Outcome measures
| Measure |
EDP-323 High Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last)
First Dose: EDP-323
|
15626.46 h*ng/mL
Standard Deviation 5982.746
|
16703.77 h*ng/mL
Standard Deviation 7268.939
|
—
|
|
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last)
Last Dose: EDP-323
|
31084.37 h*ng/mL
Standard Deviation 13945.732
|
13816.76 h*ng/mL
Standard Deviation 7801.297
|
—
|
|
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last)
First Dose: EP-038725
|
7181.42 h*ng/mL
Standard Deviation 3848.438
|
8319.19 h*ng/mL
Standard Deviation 3563.734
|
—
|
|
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last)
Last Dose: EP-038725
|
10814.63 h*ng/mL
Standard Deviation 5619.005
|
3174.73 h*ng/mL
Standard Deviation 1641.754
|
—
|
|
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last)
First Dose: EP-039082
|
26.11 h*ng/mL
Standard Deviation 21.928
|
31.34 h*ng/mL
Standard Deviation 28.251
|
—
|
|
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last)
Last Dose: EP-039082
|
35.35 h*ng/mL
Standard Deviation 28.171
|
4.77 h*ng/mL
Standard Deviation 4.119
|
—
|
SECONDARY outcome
Timeframe: Last Dose: Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose)Population: PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint.
Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The AUCs were calculated using linear up/log down method. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by \>20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table.
Outcome measures
| Measure |
EDP-323 High Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve Over the Dosing Interval (AUC0-tau)
Last Dose: EP-039082
|
48.21 h*ng/mL
Standard Deviation 26.600
|
7.31 h*ng/mL
Standard Deviation 10.464
|
—
|
|
Area Under the Concentration-time Curve Over the Dosing Interval (AUC0-tau)
Last Dose: EDP-323
|
21585.30 h*ng/mL
Standard Deviation 7915.479
|
9653.80 h*ng/mL
Standard Deviation 4245.794
|
—
|
|
Area Under the Concentration-time Curve Over the Dosing Interval (AUC0-tau)
Last Dose: EP-038725
|
8944.82 h*ng/mL
Standard Deviation 4528.012
|
2588.19 h*ng/mL
Standard Deviation 1379.765
|
—
|
SECONDARY outcome
Timeframe: Day -2 to Day 12Population: Safety Analysis Set (Treated Participants): All participants having received challenge virus and IMP.
An AE was defined as any untoward medical occurrence in clinical study participants administered a pharmaceutical (investigational or non-investigation) product. An AE does not necessarily have a causal relationship with the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: * Resulted in death * Was life threatening * Required inpatient hospitalization or prolongation of existing hospitalization * Resulted in persistent disability/incapacity * Was a congenital anomaly/birth defect * Was an important medical event
Outcome measures
| Measure |
EDP-323 High Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) up to Discharge
Any AE
|
13 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Adverse Events (AEs) up to Discharge
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Safety Analysis Set (Treated Participants): All participants having received challenge virus and IMP.
An AE was defined as any untoward medical occurrence in clinical study participants administered a pharmaceutical (investigational or non-investigation) product. An AE does not necessarily have a causal relationship with the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death * Was life threatening * Required inpatient hospitalization or prolongation of existing hospitalization * Resulted in persistent disability/incapacity * Was a congenital anomaly/birth defect * Was an important medical event
Outcome measures
| Measure |
EDP-323 High Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=47 Participants
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
Any TEAEs
|
11 Participants
|
14 Participants
|
13 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Any Treatment-emergent SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
EDP-323 High Dose
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
EDP-323 Low Dose
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Enrolled But Not Randomized
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EDP-323 High Dose
n=47 participants at risk
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days.
|
EDP-323 Low Dose
n=47 participants at risk
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days.
|
Placebo
n=47 participants at risk
Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days.
|
Enrolled But Not Randomized
Participant received RSV-A Memphis 37b virus inoculation on Day 0 but was not randomized to receive EDP-323 or matched placebo.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
6.4%
3/47 • Number of events 3 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
4.3%
2/47 • Number of events 2 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Infections and infestations
Breast abscess
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Infections and infestations
Epididymitis
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Nervous system disorders
Headache
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
4.3%
2/47 • Number of events 2 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Nervous system disorders
Presyncope
|
4.3%
2/47 • Number of events 2 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Nervous system disorders
Paraesthesia
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Nervous system disorders
Syncope
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
4.3%
2/47 • Number of events 2 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
4.3%
2/47 • Number of events 2 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Investigations
Diagnostic procedure
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
General disorders
Non-cardiac chest pain
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
General disorders
Chest discomfort
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Psychiatric disorders
Anxiety
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Psychiatric disorders
Stress
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Eye disorders
Conjunctival hyperemia
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Nervous system disorders
Dizziness
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
0.00%
0/47 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
2.1%
1/47 • Number of events 1 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
—
0/0 • All-cause mortality: Day -2 to Day 28; all adverse events: Day -2 to Day 28
All-cause mortality: Safety Analysis Set - All participants having received challenge virus, regardless of whether they received IMP or not; Adverse events: Safety Analysis Set (Treated Participants) - All participants having received challenge virus and IMP
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place