Part 1: Quantitative Viral Culture-Confirmed Influenza Infection Day 1 to Discharge
The proportion of participants with one quantifiable ≥LLOQ influenza challenge virus measurement from quantitative viral culture from a nasopharyngeal sample.
Part 1: Quantitative Viral Culture-Confirmed Influenza Infection Day 2 to Discharge
The proportion of participants with one quantifiable ≥LLOQ influenza challenge virus measurement from quantitative viral culture from a nasopharyngeal sample.
Part 1: VL-AUC by Quantitative Viral Culture Day 1 to Discharge
VL-AUC is the area under the viral load-time curve of influenza challenge virus nasopharyngeal samples to be determined by quantitative viral culture.
Part 1: VL-AUC by qRT-PCR Day 1 to Discharge
VL-AUC is the area under the viral load-time curve of influenza challenge virus nasopharyngeal samples to be determined by qRT-PCR.
Part 1: VL-AUC by Quantitative Viral Culture Day 2 to Discharge
VL-AUC is the area under the viral load-time curve of influenza challenge virus nasopharyngeal samples to be determined by quantitative viral culture.
Part 1: VL-AUC by qRT-PCR Day 2 to Discharge
VL-AUC is the area under the viral load-time curve of influenza challenge virus nasopharyngeal samples to be determined by qRT-PCR.
Part 1: PVL by qRT-PCR Day 1 to Discharge
PVL is the maximum viral load of influenza challenge virus from nasopharyngeal samples to be determined by qRT-PCR.
Part 1: PVL by Quantitative Viral Culture Day 1 to Discharge
PVL is the maximum viral load of influenza challenge virus from nasopharyngeal samples to be determined by quantitative viral culture.
Part 1: PVL by qRT-PCR Day 2 to Discharge
PVL is the maximum viral load of influenza challenge virus from nasopharyngeal samples to be determined by qRT-PCR.
Part 1: PVL by Quantitative Viral Culture Day 2 to Discharge
PVL is the maximum viral load of influenza challenge virus from nasopharyngeal samples to be determined by quantitative viral culture.
Part 1: Duration of Quantifiable Influenza by qRT-PCR Day 1 to Discharge
Time in days from the first quantifiable (≥LLOQ) influenza challenge virus measurement until the first confirmed unquantifiable (<LLOQ detected or not detected) assessment after the peak measure after which there are no more confirmed quantifiable samples). To be determined by qRT-PCR.
Part 1: Duration of Quantifiable Influenza by Quantitative Viral Culture Day 1 to Discharge
Time in days from the first quantifiable (≥LLOQ) influenza challenge virus measurement until the first confirmed unquantifiable (<LLOQ detected or not detected) assessment after the peak measure after which there are no more confirmed quantifiable samples). To be determined by quantitative viral culture.
Part 1: Duration of Quantifiable Influenza by qRT-PCR Day 2 to Discharge
Time in days from the first quantifiable (≥LLOQ) influenza challenge virus measurement until the first confirmed unquantifiable (<LLOQ detected or not detected) assessment after the peak measure after which there are no more confirmed quantifiable samples). To be determined by qRT-PCR.
Part 1: Duration of Quantifiable Influenza by Quantitative Viral Culture Day 2 to Discharge
Time in days from the first quantifiable (≥LLOQ) influenza challenge virus measurement until the first confirmed unquantifiable (<LLOQ detected or not detected) assessment after the peak measure after which there are no more confirmed quantifiable samples). To be determined by quantitative viral culture.
Part 1: Area Under the Total Symptom Score-Time Curve (TSS-AUC) Day 1 to Discharge
TSS-AUC as measured by graded symptom scoring system collected 3 times daily. Each symptom is graded where a higher grade represents a higher symptom intensity/impact.
Part 1: TSS-AUC Day 2 to Discharge
TSS-AUC as measured by graded symptom scoring system collected 3 times daily. Each symptom is graded where a higher grade represents a higher symptom intensity/impact.
Part 1: Peak Total Symptom Score (TSS) Day 1 to Discharge
Maximum TSS as measured by graded symptom scoring system collected 3 times daily.
Part 1: Peak TSS Day 2 to Discharge
Maximum TSS as measured by graded symptom scoring system collected 3 times daily.
Part 1: Duration in Days of Grade ≥2 Symptoms Day 1 to Discharge
Duration of time in days from the first occurrence of any symptom assigned Grade 2 or higher, to the beginning of the first 24-hour period without any symptom assigned Grade 2 or higher, after the peak TSS.
Part 1: Duration in Days of Grade ≥2 Symptoms Day 2 to Discharge
Duration of time in days from the first occurrence of any symptom assigned Grade 2 or higher, to the beginning of the first 24-hour period without any symptom assigned Grade 2 or higher, after the peak TSS.
Part 1: Time in Days to Symptom Resolution Day 1 to Discharge
Time in days from the beginning of the specified time frame until the beginning of a 24-hour period with no symptoms above the baseline maximum TSS, as measured by graded symptom scoring system collected 3 times daily. Baseline maximum is defined as the maximum TSS on Day -1.
Part 1: Time in Days to Symptom Resolution Day 2 to Discharge
Time in days from the beginning of the specified time frame until the beginning of a 24-hour period with no symptoms above the baseline maximum TSS, as measured by graded symptom scoring system collected 3 times daily. Baseline maximum is defined as the maximum TSS on Day -1.
Part 1: Time in Days to Peak Daily Maximum TSS Day 1 to Discharge
Time in days from the beginning of the specified time frame to the time of the peak daily maximum TSS.
Part 1: Time in Days to Peak Daily Maximum TSS Day 2 to Discharge
Time in days from the beginning of the specified time frame to the time of the peak daily maximum TSS.
Part 2, Panel A: VL-AUC by Quantitative Viral Culture
VL-AUC is the area under the viral load-time curve of influenza challenge virus nasopharyngeal samples to be determined by quantitative viral culture.
Part 2, Panel A: VL-AUC by qRT-PCR
VL-AUC is the area under the viral load-time curve of influenza challenge virus nasopharyngeal samples to be determined by qRT-PCR.
Part 2, Panel A: PVL by qRT-PCR
PVL is the maximum viral load of influenza challenge virus from nasopharyngeal samples to be determined by qRT-PCR.
Part 2, Panel A: qRT-PCR-Confirmed Influenza Infection
The proportion of participants witht wo quantifiable (≥ LLOQ) influenza challenge virus qRT-PCR measurements reported on ≥2 independent nasopharyngeal samples over 2 days.
Part 2, Panel A: qRT-PCR-Confirmed Symptomatic Influenza Infection
The proportion of participants with two quantifiable (≥ LLOQ) influenza challenge virus qRT-PCR measurements reported on ≥2 independent nasopharyngeal samples over 2 days AND TSS ≥2 at ≥1 time point following inoculation.
Part 2, Panel A: qRT-PCR-Confirmed Moderately Severe Symptomatic Influenza Infection
The proportion of participants with two quantifiable (≥ LLOQ) influenza challenge virus qRT-PCR measurements reported on ≥2 independent nasopharyngeal samples over 2 days AND any symptom of Grade ≥2 at ≥1 timepoint following inoculation.
Part 2, Panel A: qRT-PCR-Confirmed Febrile Influenza Infection
The proportion of participants with two quantifiable (≥ LLOQ) influenza challenge virus qRT-PCR measurements reported on ≥2 independent nasopharyngeal samples over 2 days AND temperature of ≥37.9 degrees Celsius at ≥1 timepoint following inoculation.
Part 2, Panel A: Quantitative Viral Culture-Confirmed Influenza Infection
The proportion of participants with one quantifiable ≥LLOQ influenza challenge virus measurement from quantitative viral culture from a nasopharyngeal sample.
Part 2, Panel A: Quantitative Viral Culture-Confirmed Symptomatic Influenza Infection
The proportion of participants with one quantifiable ≥LLOQ influenza challenge virus measurement from quantitative viral culture from a nasopharyngeal sample AND TSS ≥2 at ≥1 timepoint following inoculation.
Part 2, Panel A: Duration of Quantifiable Influenza by qRT-PCR
Time in days from the first quantifiable (≥LLOQ) influenza challenge virus measurement until the first confirmed unquantifiable (<LLOQ detected or not detected) assessment after the peak measure after which there are no more confirmed quantifiable samples). To be determined by qRT-PCR.
Part 2, Panel A: Duration of Quantifiable Influenza by Quantitative Viral Culture
Time in days from the first quantifiable (≥LLOQ) influenza challenge virus measurement until the first confirmed unquantifiable (<LLOQ detected or not detected) assessment after the peak measure after which there are no more confirmed quantifiable samples). To be determined by quantitative viral culture.
Part 2, Panel A: Time in Days to Confirmed Negative Test by qRT-PCR
Time in days from the beginning of the specified time frame until the first confirmed unquantifiable (<LLOQ detected or not detected) assessment after the peak measure after which there are no more confirmed quantifiable samples. To be determined by qRT-PCR.
Part 2, Panel A: Time in Days to Confirmed Negative Test by Quantitative Viral Culture
Time in days from the beginning of the specified time frame until the first confirmed unquantifiable (<LLOQ detected or not detected) assessment after the peak measure after which there are no more confirmed quantifiable samples. To be determined by quantitative viral culture.
Part 2, Panel A: Time in Days to Peak Viral Load by qRT-PCR
Time in days from the beginning of the specified time frame until the peak viral load measurement to be determined by qRT-PCR.
Part 2, Panel A: Time in Days to Peak Viral Load by Quantitative Viral Culture
Time in days from the beginning of the specified time frame until the peak viral load measurement to be determined by quantitative viral culture.
Part 2, Panel C: VL-AUC by Quantitative Viral Culture
VL-AUC is the area under the viral load-time curve of influenza challenge virus nasopharyngeal samples to be determined by quantitative viral culture.
Part 2, Panel B & C: VL-AUC by qRT-PCR
VL-AUC is the area under the viral load-time curve of influenza challenge virus nasopharyngeal samples to be determined by qRT-PCR.
Part 2, Panel B & C: PVL by qRT-PCR
PVL is the maximum viral load of influenza challenge virus from nasopharyngeal samples to be determined by qRT-PCR.
Part 2, Panel B & C: PVL by Quantitative Viral Culture
PVL is the maximum viral load of influenza challenge virus from nasopharyngeal samples to be determined by quantitative viral culture.
Part 2, Panel B & C: Duration of Quantifiable Influenza by qRT-PCR
Time in days from the first quantifiable (≥LLOQ) influenza challenge virus measurement until the first confirmed unquantifiable (<LLOQ detected or not detected) assessment after the peak measure after which there are no more confirmed quantifiable samples). To be determined by qRT-PCR.
Part 2, Panel B & C: Duration of Quantifiable Influenza by Quantitative Viral Culture
Time in days from the first quantifiable (≥LLOQ) influenza challenge virus measurement until the first confirmed unquantifiable (<LLOQ detected or not detected) assessment after the peak measure after which there are no more confirmed quantifiable samples). To be determined by quantitative viral culture.
Part 2, Panel B & C: Time in Days to Confirmed Negative Test by qRT-PCR
Time in days from the beginning of the specified time frame until the first confirmed unquantifiable (<LLOQ detected or not detected) assessment after the peak measure after which there are no more confirmed quantifiable samples. To be determined by qRT-PCR.
Part 2, Panel B & C: Time in Days to Confirmed Negative Test by Quantitative Viral Culture
Time in days from the beginning of the specified time frame until the first confirmed unquantifiable (<LLOQ detected or not detected) assessment after the peak measure after which there are no more confirmed quantifiable samples. To be determined by quantitative viral culture.
Part 2, Panel B & C: Time in Days to Peak Viral Load by qRT-PCR
Time in days from the beginning of the specified time frame until the peak viral load measurement to be determined by qRT-PCR.
Part 2, Panel B & C: Time in Days to Peak Viral Load by Quantitative Viral Culture
Time in days from the beginning of the specified time frame until the peak viral load measurement to be determined by quantitative viral culture.
Part 2, Panel A: TSS-AUC Day 1 to Discharge
TSS-AUC as measured by graded symptom scoring system collected 3 times daily. Each symptom is graded where a higher grade represents a higher symptom intensity/impact.
Part 2, Panel B & C: TSS-AUC Day 2 to Discharge
TSS-AUC as measured by graded symptom scoring system collected 3 times daily. Each symptom is graded where a higher grade represents a higher symptom intensity/impact.
Part 2, Panel A: Peak TSS Day 1 to Discharge
Maximum TSS as measured by graded symptom scoring system collected 3 times daily.
Part 2, Panel B & C: Peak TSS Day 2 to Discharge
Maximum TSS as measured by graded symptom scoring system collected 3 times daily.
Part 2, Panel A: Daily Maximum TSS Day 1 to Discharge
Maximum TSS on each day, measured by graded symptom scoring system.
Part 2, Panel B & C: Daily Maximum TSS Day 2 to Discharge
Maximum TSS on each day, measured by graded symptom scoring system.
Part 2, Panel A: Duration in Days of Grade ≥2 Symptoms Day 1 to Discharge
Duration of time in days from the first occurrence of any symptom assigned Grade 2 or higher, to the beginning of the first 24-hour period without any symptom assigned Grade 2 or higher, after the peak TSS.
Part 2, Panel B & C: Duration in Days of Grade ≥2 Symptoms Day 2 to Discharge
Duration of time in days from the first occurrence of any symptom assigned Grade 2 or higher, to the beginning of the first 24-hour period without any symptom assigned Grade 2 or higher, after the peak TSS.
Part 2, Panel A: Time in Days to Symptom Resolution Day 1 to Discharge
Time in days from the beginning of the specified time frame until the beginning of a 24-hour period with no symptoms above the baseline maximum TSS, as measured by graded symptom scoring system collected 3 times daily. Baseline maximum is defined as the maximum TSS on Day -1.
Part 2, Panel B & C: Time in Days to Symptom Resolution Day 2 to Discharge
Time in days from the beginning of the specified time frame until the beginning of a 24-hour period with no symptoms above the baseline maximum TSS, as measured by graded symptom scoring system collected 3 times daily. Baseline maximum is defined as the maximum TSS on Day -1.
Part 2, Panel A: Time in Days to Peak Daily Maximum TSS Day 1 to Discharge
Time in days from the beginning of the specified time frame to the time of the peak daily maximum TSS.
Part 2, Panel B & C: Time in Days to Peak Daily Maximum TSS Day 2 to Discharge
Time in days from the beginning of the specified time frame to the time of the peak daily maximum TSS.
Part 2, Panels A & B: Number of Participants with One or More AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Part 2, Panels A & B: Number of Participants who Discontinue Study Drug Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Part 2, Panels A & B: Number of Participants with One or More Viral Challenge-Related AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE is viral challenge-related as determined by investigator.
Part 2, Panels A & B: Number of Participants with Viral Challenge-Related Concomitant Medication Use
The number of participants who use at least 1 concomitant medication.
Part 2, Panels A & B: Maximum Plasma Concentration (Cmax) of N-hydroxycytidine (NHC)
The Cmax of NHC will be reported.
Part 2, Panels A & B: Time to Maximum Plasma Concentration (Tmax) of NHC
The Tmax of NHC will be reported.
Part 2, Panels A & B: Half Life (t1/2) of NHC
The t1/2 of NHC will be reported.
Part 2, Panels A & B: Area Under the Plasma Concentration From 0 to 12 Hours Postdose (AUC0-12) of NHC
The AUC0-12 of NHC will be reported.
Part 2, Panels A & B: Area Under the Plasma Concentration From 0 to Time of the Last Quantifiable Concentration after Dosing (AUC0-last) of NHC
The AUC0-last of NHC will be reported.
Part 2, Panels A & B: Trough Concentration (Ctrough) of NHC
The Ctrough of NHC will be reported.