Trial Outcomes & Findings for A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection. (NCT NCT04225897)

NCT ID: NCT04225897

Last Updated: 2024-10-23

Results Overview

An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: From start of IMP on Day 1 up to Day 7
• Results posted on: 2024-10-23

Participant Flow

This study was planned to be conducted in 3 parts: Part A, B and optional part C. Part C was not conducted as part of a reassessment of the clinical development plan for RV521 (sisunatovir); hence, data is not reported for Part C in any section of the results. A total of 51 participants were enrolled in the study (Part A=19 and Part B=32).

Participant milestones

Measure	Cohort 1: RV521 1.0 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with respiratory syncytial virus lower respiratory tract infection (RSV LRTI) received a single dose of 1.0 milligram per kilogram (mg/kg) of RV521 orally on Day 1.	Cohort 1: RV521 2.0 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.0 mg/kg of RV521 orally on Day 1.	Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: Placebo Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received placebo every 12 hours twice daily (BID) orally for 5 days.	Cohort 3: RSV1 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A (Screening Visit to Day 7) STARTED	3	7	3	6	0	0	0	0	0	0	0	0
Part A (Screening Visit to Day 7) Treated	3	7	3	6	0	0	0	0	0	0	0	0
Part A (Screening Visit to Day 7) COMPLETED	3	6	1	6	0	0	0	0	0	0	0	0
Part A (Screening Visit to Day 7) NOT COMPLETED	0	1	2	0	0	0	0	0	0	0	0	0
Part B (Screening Visit to Day 12) STARTED	0	0	0	0	3	3	4	3	1	4	6	8
Part B (Screening Visit to Day 12) Treated	0	0	0	0	3	3	4	3	1	4	6	8
Part B (Screening Visit to Day 12) COMPLETED	0	0	0	0	3	3	4	2	1	4	6	8
Part B (Screening Visit to Day 12) NOT COMPLETED	0	0	0	0	0	0	0	1	0	0	0	0

Reasons for withdrawal

Measure	Cohort 1: RV521 1.0 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with respiratory syncytial virus lower respiratory tract infection (RSV LRTI) received a single dose of 1.0 milligram per kilogram (mg/kg) of RV521 orally on Day 1.	Cohort 1: RV521 2.0 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.0 mg/kg of RV521 orally on Day 1.	Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: Placebo Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received placebo every 12 hours twice daily (BID) orally for 5 days.	Cohort 3: RSV1 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A (Screening Visit to Day 7) Adverse Event	0	1	0	0	0	0	0	0	0	0	0	0
Part A (Screening Visit to Day 7) Lost to Follow-up	0	0	1	0	0	0	0	0	0	0	0	0
Part A (Screening Visit to Day 7) Parent/legal guardian request	0	0	1	0	0	0	0	0	0	0	0	0
Part B (Screening Visit to Day 12) Parent/legal guardian request	0	0	0	0	0	0	0	1	0	0	0	0

Baseline Characteristics

A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.

Baseline characteristics by cohort

Measure	Cohort 1: RV521 1.0 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 1.0 milligram per kilogram (mg/kg) of RV521 orally on Day 1.	Cohort 1: RV521 2.0 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.0 mg/kg of RV521 orally on Day 1.	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: Placebo n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received placebo every 12 hours twice daily (BID) orally for 5 days.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: Placebo n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Total n=50 Participants Total of all reporting groups
Age, Customized 28 days to 23 months	1 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	8 Participants n=42 Participants	42 Participants n=36 Participants
Age, Customized 2 to 11 years	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	8 Participants n=36 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	5 Participants n=42 Participants	19 Participants n=36 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	3 Participants n=42 Participants	31 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	9 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	7 Participants n=42 Participants	40 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	16 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	6 Participants n=42 Participants	28 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants

PRIMARY outcome

Timeframe: From start of IMP on Day 1 up to Day 7

Population: Safety population included all participants who received at least 1 dose of IMP.

An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP TEAEs	3 Participants	1 Participants	2 Participants	5 Participants	—	—	—	—
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP SAEs	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP TEAEs leading to permanent discontinuation of IMP	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: From start of IMP on Day 1 up to Day 12

Population: Safety population included all participants who received at least 1 dose of IMP.

An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP TEAEs	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants	2 Participants	3 Participants	1 Participants
Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP TEAEs leading to permanent discontinuation of IMP	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Physical examination included general appearance; head, eyes, ears, nose and throat (HEENT); dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline General appearance	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline HEENT	0 Participants	0 Participants	1 Participants	2 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline Dermatologic	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline Cardiovascular	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline Respiratory	2 Participants	1 Participants	3 Participants	6 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline Gastrointestinal	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline Neurological	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Anytime between 18 to 24 hours post-dose on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=6 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose General appearance	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose HEENT	0 Participants	0 Participants	1 Participants	2 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose Gastrointestinal	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose Dermatologic	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose Cardiovascular	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose Respiratory	1 Participants	1 Participants	1 Participants	4 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose Neurological	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: At 48 hours post-dose on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=6 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose General appearance	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose Dermatologic	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose Cardiovascular	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose Respiratory	1 Participants	1 Participants	1 Participants	3 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose HEENT	1 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose Gastrointestinal	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose Neurological	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=7 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline General Appearance	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline Cardiovascular	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline Neurological	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline HEENT	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline Dermatologic	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline Respiratory	3 Participants	3 Participants	1 Participants	2 Participants	1 Participants	2 Participants	4 Participants	3 Participants
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline Gastrointestinal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Anytime between 40 to 48 hours post-dose 10 on Day 5

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 Dermatologic	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 Respiratory	0 Participants	0 Participants	0 Participants	1 Participants	—	1 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 Neurological	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 General appearance	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 HEENT	1 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 Cardiovascular	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 Gastrointestinal	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Anytime between 4 to 5 hours post-dose on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: At 12 hours post-dose on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Anytime between 18 to 24 hours post-dose on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=6 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-Dose	0 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 48 hours post-dose on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=6 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 48 Hours Post-Dose	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Anytime between 4 to 5 hours post-dose 1 (Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 2 (Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 2= assessment prior to receiving dose 2 of IMP on Day 1.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 3 (Day 2)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 3= assessment prior to receiving dose 3 of IMP on Day 2.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 4 (Day 2)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 4= assessment prior to receiving dose 4 of IMP on Day 2.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 5 (Day 3)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 5= assessment prior to receiving dose 5 of IMP on Day 3.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 6 (Day 3)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 6= assessment prior to receiving dose 6 of IMP on Day 3.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Anytime between 4 to 5 hours post-dose 6 (Day 3)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 7 (Day 4)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 7= assessment prior to receiving dose 7 of IMP on Day 4.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 8 (Day 4)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 8= assessment prior to receiving dose 8 of IMP on Day 4.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 9 (Day 5)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 9= assessment prior to receiving dose 9 of IMP on Day 5.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 10 (Day 5)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 10= assessment prior to receiving dose 10 of IMP on Day 5.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Anytime between 40 to 48 hours post-dose 10 on Day 5

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Hematology parameters included basophils, eosinophils, mean cell hemoglobin concentration (MCHC), mean cell hemoglobin (MCH), mean cell volume (MCV), red blood cell count (RBC), hematocrit (HCT), hemoglobin (Hb), white blood cell count (WBC), lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Hematology Results at Baseline MCHC; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline MCV; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline RBC; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline HCT; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Lymphocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Lymphocytes; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Monocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Monocytes; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Neutrophils; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Neutrophils; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Basophils; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Basophils; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Eosinophils; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Eosinophils; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline MCHC; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline MCH; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline MCH; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline MCV; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline RBC; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline HCT; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Hb; below normal range	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Hb; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline WBC; below normal range	1 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline WBC; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Platelets; below normal range	0 Participants	1 Participants	0 Participants	2 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at Baseline Platelets; above normal range	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: At 48 hours post-dose on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=6 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Basophils; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Eosinophils; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose MCHC; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose MCHC; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose WBC; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Lymphocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Neutrophils; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Basophils; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Eosinophils; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose MCH; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose MCH; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose MCV; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose MCV; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose RBC; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose RBC; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose HCT; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose HCT; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Hb; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Hb; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose WBC; above normal range	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Lymphocytes; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Monocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Monocytes; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Neutrophils; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Platelets; below normal range	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose Platelets; above normal range	1 Participants	1 Participants	1 Participants	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=7 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Hematology Results at Baseline Basophils; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Hb; below normal range	1 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Hb; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline WBC; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Lymphocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Lymphocytes; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Monocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Neutrophils; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Platelets; below normal range	1 Participants	0 Participants	1 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Platelets; above normal range	0 Participants	0 Participants	1 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Basophils; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Eosinophils; below normal range	1 Participants	0 Participants	1 Participants	0 Participants	—	0 Participants	0 Participants	2 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Eosinophils; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline MCHC; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline MCHC; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline MCH; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline MCH; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline MCV; below normal range	1 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline MCV; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline RBC; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline RBC; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline HCT; below normal range	0 Participants	1 Participants	0 Participants	0 Participants	—	0 Participants	2 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline HCT; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline WBC; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	2 Participants	1 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Monocytes; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results at Baseline Neutrophils; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Anytime between 40 to 48 hours post-dose 10 on Day 5

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=7 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Basophils; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Eosinophils; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Eosinophils; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 MCHC; below normal range	1 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 MCHC; above normal range	0 Participants	1 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 MCV; below normal range	1 Participants	1 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 RBC; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 HCT; above normal range	1 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Hb; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 WBC; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Platelets; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Platelets; above normal range	2 Participants	0 Participants	2 Participants	1 Participants	—	0 Participants	2 Participants	6 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Basophils; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 MCH; below normal range	0 Participants	1 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 MCH; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 MCV; above normal range	1 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 RBC; above normal range	2 Participants	1 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 HCT; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	2 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Hb; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 WBC; above normal range	0 Participants	0 Participants	1 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Lymphocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Lymphocytes; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Monocytes; below normal range	1 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Monocytes; above normal range	1 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Neutrophils; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	1 Participants
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 Neutrophils; above normal range	1 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Clinical chemistry parameters included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, gamma glutamyltransferase (GGT), glucose, lactate dehydrogenase (LDH), potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline ALT; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Albumin; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Albumin; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline ALP; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline AST; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Chloride; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Chloride; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Creatinine; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline LDH; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Potassium; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Protein; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Sodium; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Urea; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline ALT; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline ALP; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline AST; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Bilirubin; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Bilirubin; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Calcium; below normal range	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Calcium; above normal range	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Creatinine; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline GGT; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline GGT; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Glucose; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Glucose; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline LDH; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Potassium; above normal range	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Protein; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Sodium; below normal range	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Urea; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: At 48 hours post-dose on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Albumin; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose ALP; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Calcium; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Calcium; above normal range	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Chloride; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Chloride; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Creatinine; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose GGT; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Glucose; below normal range	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Glucose; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose LDH; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Sodium; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose ALT; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose ALT; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Albumin; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose ALP; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose AST; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose AST; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Bilirubin; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Bilirubin; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Creatinine; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose GGT; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose LDH; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Potassium; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Potassium; above normal range	0 Participants	3 Participants	0 Participants	1 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Protein; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Protein; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Sodium; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Urea; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose Urea; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Glucose; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline AST; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Protein; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Sodium; below normal range	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Sodium; above normal range	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Urea; below normal range	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Glucose; above normal range	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline LDH; below normal range	0 Participants	0 Participants	—	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline ALT; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	3 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Albumin; below normal range	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Albumin; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline ALP; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Creatinine; below normal range	2 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	4 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Creatinine; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline GGT; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline GGT; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Bilirubin; below normal range	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Bilirubin; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Calcium; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Calcium; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Chloride; below normal range	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline AST; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Chloride; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline LDH; above normal range	0 Participants	1 Participants	—	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Potassium; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Potassium; above normal range	0 Participants	1 Participants	0 Participants	1 Participants	—	0 Participants	1 Participants	2 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Protein; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline Urea; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline ALT; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline ALP; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Anytime between 40 to 48 hours post-dose 10 on Day 5

Population: Safety population included all participants who received at least 1 dose of IMP. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 ALT; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 ALT; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Albumin; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Albumin; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Bilirubin; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Creatinine; below normal range	0 Participants	1 Participants	1 Participants	0 Participants	—	0 Participants	1 Participants	4 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Sodium; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 ALP; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 ALP; above normal range	1 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 AST; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 AST; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Bilirubin; below normal range	1 Participants	0 Participants	1 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Calcium; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Calcium; above normal range	1 Participants	0 Participants	0 Participants	1 Participants	—	1 Participants	0 Participants	5 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Chloride; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Chloride; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Creatinine; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Sodium; above normal range	0 Participants	1 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 GGT; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 GGT; above normal range	0 Participants	1 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Glucose; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Glucose; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 LDH; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 LDH; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Potassium; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Potassium; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Protein; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	1 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Protein; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Urea; below normal range	1 Participants	1 Participants	1 Participants	0 Participants	—	0 Participants	1 Participants	0 Participants
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 Urea; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per high power field [hpf]), erythrocytes (0 to 2 per hpf), granular casts (0 per low power field [lpf]), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline Erythrocytes; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline Hyaline casts; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline Hyaline casts; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline Leukocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline Leukocytes; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline RBC cast; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline RBC cast; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline WBC cast; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline Epithelial Cells; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline Epithelial Cells; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline Erythrocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline Granular casts; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline Granular casts; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline WBC cast; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline Waxy cast; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline Waxy cast; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline pH; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline pH; above normal range	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: At 48 hours post-dose on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and potential of hydrogen (pH) (5 to 8).

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=6 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose Epithelial Cells; below normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose Erythrocytes; below normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose Waxy cast; below normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose WBC cast; above normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose Epithelial Cells; above normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose Erythrocytes; above normal range	—	1 Participants	1 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose Granular casts; below normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose Granular casts; above normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose Hyaline casts; below normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose Hyaline casts; above normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose Leukocytes; below normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose Leukocytes; above normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose RBC cast; below normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose RBC cast; above normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose WBC cast; below normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose Waxy cast; above normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose pH; below normal range	—	0 Participants	0 Participants	0 Participants	—	—	—	—
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose pH; above normal range	—	1 Participants	0 Participants	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline Hyaline casts; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline Granular casts; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline Epithelial cells; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline Hyaline casts; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline Epithelial cells; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline Leukocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline Leukocytes; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline RBC cast; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline RBC cast; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline WBC cast; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline WBC cast; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline Waxy cast; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline Waxy cast; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline Erythrocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline Erythrocytes; above normal range	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline Granular casts; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline pH; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline pH; above normal range	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Anytime between 40 to 48 hours post-dose 10 on Day 5

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Following urine parameters were analysed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 Epithelial Cells; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 Epithelial Cells; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 Erythrocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 Erythrocytes; above normal range	1 Participants	0 Participants	0 Participants	0 Participants	—	—	2 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 Granular casts; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 Granular casts; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 Hyaline casts; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 Hyaline casts; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 Leukocytes; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 Leukocytes; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	1 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 RBC cast; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 RBC cast; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 WBC cast; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 WBC cast; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 Waxy cast; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 Waxy cast; above normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 pH; below normal range	0 Participants	0 Participants	0 Participants	0 Participants	—	—	0 Participants	0 Participants
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 pH; above normal range	1 Participants	1 Participants	1 Participants	0 Participants	—	—	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QT interval corrected by Bazzett's formula (QTcB) interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Anytime between 4 to 5 hours post-dose on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Anytime between 18 to 24 hours post-dose on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=6 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-dose	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 48 hours post-dose on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=6 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at 48 Hours Post-dose	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose on Day 1)

Population: Safety population included all participants who received at least 1 dose of IMP.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Anytime between 4 to 5 hours post-dose 1 on Day 1

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 3 (Day 2)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 5 (Day 3)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Anytime between 4 to 5 hours post-dose 6 (Day 3)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=7 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 8 (Day 4)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose 10 (Day 5)

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10	0 Participants	—	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Anytime between 40 to 48 hours post-dose 10 on Day 5

Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10	0 Participants	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

Population: Pharmacokinetic (PK) population included all participants who received IMP and had at least 1 post-dose PK concentration measurement.

No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the Pharmacokinetic (PK) population.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Time to Maximum Plasma Concentration (Tmax)	7 Hours Full Range 4.87 • Interval 4.87 to 48.3	4.78 Hours Full Range 2 • Interval 2.0 to 6.67	4.17 Hours Full Range 4 • Interval 4.0 to 4.5	4.58 Hours Full Range 4.42 • Interval 4.42 to 6.18	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Time to Maximum Plasma Concentration (Tmax) Dose 1	4.17 Hours Interval 2.5 to 4.17	4.03 Hours Interval 3.77 to 5.5	4.6 Hours Interval 4.33 to 4.63	4.32 Hours Interval 3.58 to 11.6	4.31 Hours Interval 4.08 to 12.0	—	—	—
Part B: Time to Maximum Plasma Concentration (Tmax) Dose 6	4.53 Hours Interval 4.05 to 5.0	4.58 Hours Interval 3.58 to 11.5	4.43 Hours Interval 4.38 to 4.5	3.95 Hours Interval 3.67 to 4.88	4.29 Hours Interval 0.0 to 11.8	—	—	—

SECONDARY outcome

Timeframe: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement.

No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Maximum Observed Plasma Concentration (Cmax)	2.98 Nanograms per milliliter Standard Deviation 3.09 • Interval 3.09 to	28 Nanograms per milliliter Standard Deviation 17.5 • Interval 17.5 to	1.59 Nanograms per milliliter Standard Deviation 2.76 • Interval 2.76 to	8.08 Nanograms per milliliter Standard Deviation 7.94 • Interval 7.94 to	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Maximum Observed Plasma Concentration (Cmax) Dose 1	115 Nanograms per milliliter Standard Deviation 182	39.3 Nanograms per milliliter Standard Deviation 26.4	43.2 Nanograms per milliliter Standard Deviation 36.7	24.9 Nanograms per milliliter Standard Deviation 20	56.5 Nanograms per milliliter Standard Deviation 88.1	—	—	—
Part B: Maximum Observed Plasma Concentration (Cmax) Dose 6	212 Nanograms per milliliter Standard Deviation 157	133 Nanograms per milliliter Standard Deviation 64.8	30.9 Nanograms per milliliter Standard Deviation 31.3	67.8 Nanograms per milliliter Standard Deviation 86.3	177 Nanograms per milliliter Standard Deviation 151	—	—	—

SECONDARY outcome

Timeframe: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours post-dose on Day 1

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)	6.46 Hours*nanogram per milliliter Standard Deviation 9.14 • Interval 9.14 to	201 Hours*nanogram per milliliter Standard Deviation 143 • Interval 143.0 to	9.22 Hours*nanogram per milliliter Standard Deviation 16 • Interval 16.0 to	45 Hours*nanogram per milliliter Standard Deviation 48 • Interval 48.0 to	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) Dose 1	1170 Hours*nanogram per milliliter Standard Deviation 1460	127 Hours*nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	—	—	160 Hours*nanogram per milliliter Standard Deviation 120	—	—	—
Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) Dose 6	—	1110 Hours*nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	87.9 Hours*nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	184 Hours*nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	1600 Hours*nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	—	—	—

SECONDARY outcome

Timeframe: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=6 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])	14 Hours*nanogram per milliliter Standard Deviation 1.46	287 Hours*nanogram per milliliter Standard Deviation 217	23.1 Hours*nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	48.1 Hours*nanogram per milliliter Standard Deviation 49.9	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) Dose 6	1560 Hours*nanogram per milliliter Standard Deviation 1010	1310 Hours*nanogram per milliliter Standard Deviation 802	225 Hours*nanogram per milliliter Standard Deviation 233	477 Hours*nanogram per milliliter Standard Deviation 594	1140 Hours*nanogram per milliliter Standard Deviation 845	—	—	—
Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) Dose 1	1170 Hours*nanogram per milliliter Standard Deviation 1460	342 Hours*nanogram per milliliter Standard Deviation 240	288 Hours*nanogram per milliliter Standard Deviation 251	163 Hours*nanogram per milliliter Standard Deviation 132	315 Hours*nanogram per milliliter Standard Deviation 386	—	—	—

SECONDARY outcome

Timeframe: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed for Cohort 1 due to insufficient number of quantifiable sisunatovir concentrations.

T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Terminal Half-life (t1/2)	—	6.22 Hours Standard Deviation 1.46 • Interval 1.46 to	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed as at least 3 quantifiable concentrations were required to calculate t1/2 and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed for Cohort 1 as at least 3 quantifiable concentrations were required to calculate AUC(0 to inf) and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)	—	231 Hours*nanogram per milliliter Standard Deviation 161 • Interval 161.0 to	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed as at least 3 quantifiable concentrations were required to calculate AUC(0 to inf) and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 12 hours post-dose on Day 1

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=6 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=7 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Trough Concentration at the End of First Dosing Interval (C12)	1.06 Nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	10.4 Nanogram per milliliter Standard Deviation 9.57	NA Nanogram per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	0.851 Nanogram per milliliter Standard Deviation 1.52	—	—	—	—

SECONDARY outcome

Timeframe: At 12 hours post-dose 6

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Trough Concentration at the End of Dose 6 (C12)	36.9 Nanograms per milliliter Standard Deviation 5.3 • Interval 5.3 to	89.8 Nanograms per milliliter Standard Deviation 99.1 • Interval 99.1 to	7.6 Nanograms per milliliter Standard Deviation 8.33 • Interval 8.33 to	9.55 Nanograms per milliliter Standard Deviation 9.75 • Interval 9.75 to	124 Nanograms per milliliter Standard Deviation 167 • Interval 167.0 to	—	—	—

SECONDARY outcome

Timeframe: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed for Cohort 1 as at least 3 quantifiable concentrations were required to calculate clearance and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

Clearance was calculated as Dose divided by AUC(0 to inf). No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Predicted Plasma Clearance	—	12.7 Liters per hour per kilogram Standard Deviation 7.66 • Interval 7.66 to	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed as at least 3 quantifiable concentrations were required to calculate clearance and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

Clearance was calculated as Dose divided by AUC(0 to inf). No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed for Cohort 1 as at least 3 quantifiable concentrations were required to calculate volume of distribution and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

Apparent volume of distribution was estimated as Dose/Kel*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part A: Apparent Volume of Distribution of the Drug After Extravascular Administration	—	119 Litres per kilogram Standard Deviation 87.4 • Interval 87.4 to	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed as at least 3 quantifiable concentrations were required to calculate volume of distribution and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

Apparent volume of distribution was estimated as Dose/Kel*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Accumulation ratio could not be calculated as it was depended on AUC which was not calculable due to insufficient number of quantifiable concentrations.

Accumulation ratio was calculated as ratio of the area under the curve (AUC) during a single dosing interval under steady state conditions to the AUC during a dosing interval after one singe dose. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Percentage fluctuation was calculated as 100*(Cmax-Cmin)/Cavg, where Cmin=minimum plasma concentration and Cmax measured over dosing interval.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Percentage Fluctuation	—	8.63 Percentage of fluctuation Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	132 Percentage of fluctuation Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	123 Percentage of fluctuation Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	98.1 Percentage of fluctuation Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	—	—	—

SECONDARY outcome

Timeframe: Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

AUC(0 to tau) was determined using the linear trapezoidal method.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the End of Last Dosing Interval (AUC0-tau)	—	1110 Hours*nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	87.9 Hours*nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	184 Hours*nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	1600 Hours*nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	—	—	—

SECONDARY outcome

Timeframe: Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Cavg was estimated as AUC(0 to tau)/tau, where tau=dosing interval (12 hours).

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=1 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Average Plasma Concentration Over Dosing Interval (Cavg)	—	92.7 Nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	7.32 Nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	15.3 Nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	133 Nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	—	—	—

SECONDARY outcome

Timeframe: Day 3 Dose 6 (pre-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Minimum Observed Plasma Concentration	70.8 Nanograms per milliliter Standard Deviation 20.9	96.7 Nanograms per milliliter Standard Deviation 48.6	8.51 Nanograms per milliliter Standard Deviation 9.87	24.3 Nanograms per milliliter Standard Deviation 24.7	59.6 Nanograms per milliliter Standard Deviation 65.7	—	—	—

SECONDARY outcome

Timeframe: Day 3 Dose 6 (pre-dose)

Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=3 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Plasma Trough Concentration	70.8 Nanograms per milliliter Standard Deviation 20.9	96.7 Nanograms per milliliter Standard Deviation 48.6	8.51 Nanograms per milliliter Standard Deviation 9.87	24.3 Nanograms per milliliter Standard Deviation 24.7	59.6 Nanograms per milliliter Standard Deviation 65.7	—	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1

Population: Modified Intent to Treat (mITT) population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoints. Data for Cohorts 4 and 5 were combined as pre-specified in statistical analysis plan.

Percent change from baseline in log10 total RSV viral load was analyzed using a mixed effects analysis of covariance (ANCOVA) model. The model was fitted to the participants treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan for age group >=1 month to <6 months.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=6 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=12 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) 60 hours	—	—	-23.27 Percent change Standard Error 10.48	-31.29 Percent change Standard Error 8.19	—	—	—	—
Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) 156 hours	—	—	-32.31 Percent change Standard Error 11.52	-47.53 Percent change Standard Error 8.03	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1

Population: mITT population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoints. Data for Cohorts 4 and 5 were combined as pre-specified in statistical analysis plan.

Percent change from baseline in log10 total RSV viral load was analyzed using a mixed effects ANCOVA model. The model was fitted to the participants treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan for age group >=1 month to <6 months.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=6 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=12 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA) 60 hours	—	—	-69.56 Percent change Standard Error 46.32	-54.74 Percent change Standard Error 34.87	—	—	—	—
Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA) 156 hours	—	—	-10.00 Percent change Standard Error 51.88	-41.20 Percent change Standard Error 34.01	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 12

Population: mITT population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Time to resolution was calculated for RSV-related signs and symptoms that were present at study start and was defined as the time of randomization to the time that RSV-related signs and symptoms were absent.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Time to Resolution of RSV-Related Signs and Symptoms	6.45 Days Full Range 5.9 • Interval 5.9 to 6.8	3.80 Days Full Range 2.6 • Interval 2.6 to 5.0	6.20 Days Full Range 6.1 • Interval 6.1 to 6.6	6.20 Days Full Range 6.2 • Interval 6.2 to 6.3	4.90 Days Full Range 4.9 • Interval 4.9 to 4.9	6.30 Days Full Range 4.6 • Interval 4.6 to 6.9	6.00 Days Full Range 2.5 • Interval 2.5 to 6.7	6.10 Days Full Range 4.1 • Interval 4.1 to 6.9

SECONDARY outcome

Timeframe: Up to Day 12

Population: mITT population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Time to improvement was calculated for RSV-related signs and symptoms that were classified as moderate or severe during the course of the study and was defined as the time from randomization to the time that RSV-related signs and symptoms were mild or absent.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=2 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: Time to Improvement in RSV-Related Signs and Symptoms	3.15 Days Full Range 2.1 • Interval 2.1 to 5.9	2.55 Days Full Range 1.1 • Interval 1.1 to 4.0	2.25 Days Full Range 1.5 • Interval 1.5 to 3.0	0.50 Days Full Range 0.5 • Interval 0.5 to 6.3	1.90 Days Full Range 1.9 • Interval 1.9 to 1.9	4.35 Days Full Range 3.6 • Interval 3.6 to 6.9	3.00 Days Full Range 1.0 • Interval 1.0 to 6.0	6.00 Days Full Range 1.5 • Interval 1.5 to 6.9

SECONDARY outcome

Timeframe: Baseline (pre-dose 1 on Day 1), pre-dose 3, pre-dose 5, pre-dose 7, pre-dose 9, anytime between 40 to 48 hours post-dose 10 on Day 5

Population: mITT population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified timepoints.

RSV clinical score was a composite score for infants with RSV infection >= 1 month of age based on 4 items (respiratory rate, wheezing, retraction of respiratory muscles and general condition). Score for each item ranged from 0 to 3 where 0=none/normal and 3=severe. Total score was calculated as sum of individual items and ranged from 0 to 12, where higher score indicated severe disease. RSV symptoms were graded as mild: score <=5, moderate: score > 5 but < 9 and severe: score >=9.

Outcome measures

Measure	Cohort 1: RV521 2.5 mg/kg n=4 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Cohort 2: RV521 2.0 mg/kg n=2 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Cohort 3: RSV1 2.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 3: RV521 3.5 mg/kg n=3 Participants Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=1 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 4: RV521 2.5 mg/kg n=4 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Cohort 5: Placebo n=5 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Cohort 5: RV521 2.5 mg/kg n=8 Participants Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Part B: RSV Clinical Scoring System Scores pre-dose 5	1.8 Units on a scale Standard Deviation 1.50	2.5 Units on a scale Standard Deviation 3.54	1.0 Units on a scale Standard Deviation 1.00	2.7 Units on a scale Standard Deviation 2.08	3.0 Units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	3.3 Units on a scale Standard Deviation 0.96	1.4 Units on a scale Standard Deviation 1.14	3.9 Units on a scale Standard Deviation 2.75
Part B: RSV Clinical Scoring System Scores pre-dose 3	2.5 Units on a scale Standard Deviation 1.29	1.0 Units on a scale Standard Deviation 1.41	2.0 Units on a scale Standard Deviation 1.73	4.0 Units on a scale Standard Deviation 2.65	4.0 Units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	5.0 Units on a scale Standard Deviation 0.00	1.8 Units on a scale Standard Deviation 1.10	4.3 Units on a scale Standard Deviation 2.38
Part B: RSV Clinical Scoring System Scores Baseline	6.8 Units on a scale Standard Deviation 2.50	4.5 Units on a scale Standard Deviation 6.36	3.5 Units on a scale Standard Deviation 2.12	5.0 Units on a scale Standard Deviation 1.73	8.0 Units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	6.8 Units on a scale Standard Deviation 2.22	6.2 Units on a scale Standard Deviation 3.56	6.0 Units on a scale Standard Deviation 2.73
Part B: RSV Clinical Scoring System Scores pre-dose 7	1.3 Units on a scale Standard Deviation 1.50	2.5 Units on a scale Standard Deviation 3.54	0.7 Units on a scale Standard Deviation 0.58	3.0 Units on a scale Standard Deviation 1.73	1.0 Units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	1.3 Units on a scale Standard Deviation 0.58	1.6 Units on a scale Standard Deviation 0.55	2.3 Units on a scale Standard Deviation 2.12
Part B: RSV Clinical Scoring System Scores pre-dose 9	1.5 Units on a scale Standard Deviation 0.71	1.0 Units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	0.0 Units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	3.5 Units on a scale Standard Deviation 2.12	1.0 Units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.	2.0 Units on a scale Standard Deviation 1.41	1.8 Units on a scale Standard Deviation 0.50	2.3 Units on a scale Standard Deviation 0.96
Part B: RSV Clinical Scoring System Scores 40 to 48 hours post-dose 10	0.5 Units on a scale Standard Deviation 0.58	0.0 Units on a scale Standard Deviation 0.00	0.3 Units on a scale Standard Deviation 0.58	1.0 Units on a scale Standard Deviation 1.00	—	1.0 Units on a scale Standard Deviation 1.00	1.2 Units on a scale Standard Deviation 1.10	0.6 Units on a scale Standard Deviation 0.52

Adverse Events

Part A: Cohort 1: RV521 1.0 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A: Cohort 1: RV521 2.0 mg/kg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A: Cohort 1: RV521 2.5 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A: Cohort 2: RV521 2.0 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Cohort 3: Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Cohort 3: RSV1 2.5 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part B: Cohort 3: RV521 3.5 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Cohort 3: RV521 5 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Cohort 4: Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Cohort 4: RV521 2.5 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part B: Cohort 5: Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B: Cohort 5: RV521 2.5 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A: Cohort 1: RV521 1.0 mg/kg n=3 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 1.0 milligram per kilogram (mg/kg) of RV521 orally on Day 1.	Part A: Cohort 1: RV521 2.0 mg/kg n=7 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.0 mg/kg of RV521 orally on Day 1.	Part A: Cohort 1: RV521 2.5 mg/kg n=3 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Part A: Cohort 2: RV521 2.0 mg/kg n=6 participants at risk Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Part B: Cohort 3: Placebo n=3 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received placebo every 12 hours twice daily (BID) orally for 5 days.	Part B: Cohort 3: RSV1 2.5 mg/kg n=3 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Part B: Cohort 3: RV521 3.5 mg/kg n=4 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Part B: Cohort 3: RV521 5 mg/kg n=3 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 5 mg/kg every 12 hours (BID) orally for 5 days.	Part B: Cohort 4: Placebo n=1 participants at risk Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Part B: Cohort 4: RV521 2.5 mg/kg n=4 participants at risk Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Part B: Cohort 5: Placebo n=5 participants at risk Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Part B: Cohort 5: RV521 2.5 mg/kg n=8 participants at risk Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
General disorders Pyrexia	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	14.3% 1/7 • Number of events 1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.

Other adverse events

Measure	Part A: Cohort 1: RV521 1.0 mg/kg n=3 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 1.0 milligram per kilogram (mg/kg) of RV521 orally on Day 1.	Part A: Cohort 1: RV521 2.0 mg/kg n=7 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.0 mg/kg of RV521 orally on Day 1.	Part A: Cohort 1: RV521 2.5 mg/kg n=3 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.	Part A: Cohort 2: RV521 2.0 mg/kg n=6 participants at risk Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.	Part B: Cohort 3: Placebo n=3 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received placebo every 12 hours twice daily (BID) orally for 5 days.	Part B: Cohort 3: RSV1 2.5 mg/kg n=3 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Part B: Cohort 3: RV521 3.5 mg/kg n=4 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.	Part B: Cohort 3: RV521 5 mg/kg n=3 participants at risk Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 5 mg/kg every 12 hours (BID) orally for 5 days.	Part B: Cohort 4: Placebo n=1 participants at risk Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Part B: Cohort 4: RV521 2.5 mg/kg n=4 participants at risk Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.	Part B: Cohort 5: Placebo n=5 participants at risk Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.	Part B: Cohort 5: RV521 2.5 mg/kg n=8 participants at risk Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	100.0% 3/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Gastrointestinal disorders Anal erythema	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	14.3% 1/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	25.0% 1/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Gastrointestinal disorders Post-tussive vomiting	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	14.3% 1/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	14.3% 1/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Cardiac disorders Sinus arrhythmia	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	14.3% 1/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Ear and labyrinth disorders Otorrhoea	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
General disorders Catheter site inflammation	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Psychiatric disorders Irritability	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	16.7% 1/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	100.0% 1/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Cardiac disorders Bradycardia	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	20.0% 1/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	20.0% 1/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
General disorders Pyrexia	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	100.0% 1/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	40.0% 2/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
General disorders Withdrawal syndrome	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	50.0% 2/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	20.0% 1/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
General disorders Oedema peripheral	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	20.0% 1/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Infections and infestations Croup infectious	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	40.0% 2/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Infections and infestations Bacterial disease carrier	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	25.0% 1/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Infections and infestations Conjunctivitis	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	12.5% 1/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Infections and infestations Respiratory tract infection bacterial	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	20.0% 1/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Infections and infestations Urinary tract infection bacterial	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	20.0% 1/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Investigations Bacterial test positive	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	25.0% 1/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Investigations Blood pressure increased	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	25.0% 1/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Investigations Monocyte count decreased	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Investigations Transaminases increased	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	25.0% 1/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	20.0% 1/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Respiratory, thoracic and mediastinal disorders Cyanosis central	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	25.0% 1/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	20.0% 1/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	20.0% 1/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	25.0% 1/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	33.3% 1/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Renal and urinary disorders Oliguria	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	100.0% 1/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.
Vascular disorders Phlebitis	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/7 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/6 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/3 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/1 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/4 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	20.0% 1/5 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.	0.00% 0/8 • From start of IMP on Day 1 up to Day 7 for Part A; From start of IMP on Day 1 up to Day 12 for Part B Same event may appear as SAE and non-SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety population included all participants who received at least 1 dose of IMP.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER