Trial Outcomes & Findings for A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV) (NCT NCT04583280)

Last Updated: 2025-02-04

Results Overview

RRS was an ordinal scale to assess a participant's clinical status. The RRS provided 7 mutually exclusive categories ordered from best (1) to worst (7) where 1 =home without signs/symptoms, 2 =home with sign/symptoms, 3 =ward without supplemental oxygen (O2) or feeding/hydration, 4 =ward with supplemental or feeding/hydration, 5 =intensive care unit (ICU) without mechanical ventilation (included both invasive and non-invasive mechanical ventilation), 6 =required mechanical ventilation and 7=worst (death). Higher category indicates worse condition. With or without signs/symptoms was defined as the key RSV signs/symptoms (breathing problems, retractions, tachypnea, cough, wheezing/breathing sounds, and tachycardia) resolved (absent or mild) or not resolved assessed by parent/caregiver.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

28 participants

Primary outcome timeframe

Baseline to Day 8

Results posted on

2025-02-04

Participant Flow

A total of 28 participants with acute respiratory tract infection due to respiratory syncytial virus (RSV) were randomized and treated (8 participants in placebo arm and 20 participants in rilematovir arm). Of these, 27 participants completed the study.

Participant milestones

Participant milestones
Measure	Placebo Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Overall Study STARTED	8	20
Overall Study COMPLETED	8	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Overall Study Consent withdrawn by parent/caregiver	0	1

Baseline Characteristics

A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=20 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).	Total n=28 Participants Total of all reporting groups
Age, Continuous	15.3 months STANDARD_DEVIATION 19.4 • n=5 Participants	16.2 months STANDARD_DEVIATION 13.67 • n=7 Participants	15.9 months STANDARD_DEVIATION 15.14 • n=5 Participants
Age, Customized Infants and toddlers(28 days-23 months)	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Age, Customized Children (2-11 years)	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 8

Population: Intent to treat - infected (ITT-i) analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Due to the early termination of study, last day of RRS treatment (Day 8) was considered instead of the original planned day defined as when 50% participants would have been discharged.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=19 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category Home without symptoms	25.0 Percentage of participants	31.6 Percentage of participants
Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category Home with symptoms	50.0 Percentage of participants	26.3 Percentage of participants
Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category Ward without supplemental oxygen/feeding/hydration	25.0 Percentage of participants	36.8 Percentage of participants
Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category Ward with supplemental or feeding/hydration	0 Percentage of participants	5.3 Percentage of participants
Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category ICU without mechanical ventilation	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category Requiring mechanical ventilation	0 Percentage of participants	0 Percentage of participants
Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category Death	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Day 8

Population: ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis.

Clinically resolved was defined as participant required no oxygen supplementation, no supplemental feeding/hydration, no need for ICU and had Key RSV signs/symptoms resolved to absent or mild as per ClinRO signs/symptoms. Clinically resolved Key RSV signs/symptoms were assessed based on clinician's observations as resolved if participant had no retractions, tachypnea, tachycardia, breathing problems (nasal flaring, head bobbing, grunting); cough (resolved if little or no coughing or occasional strong cough or sometimes productive) and wheezing (resolved if no wheezing or terminal expiratory wheezing or only with stethoscope).

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=19 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Percentage of Participants Clinically Resolved From RSV Disease Based on the Clinician Reported Outcome (ClinRO) Sign/Symptoms at Day 8	37.5 Percentage of participants	31.6 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 21

Population: ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had RSV infection confirmed by central laboratory analysis.

Time (in hours) from first dose of study intervention to first resolution of key RSV signs/symptoms was evaluated based on ObsRO assessment after free of supplementation (O2/feeding/hydration) for at least 24 hours. Clinically resolved was defined as participant required no oxygen supplementation, no supplemental feeding/hydration, no need for ICU and had key RSV signs/symptoms resolved to absent or mild as per ObsRO signs/symptoms. Resolution of key signs/symptoms assessment was based on observations of child's parent/caregiver as resolved if no retractions, tachypnea, tachycardia, breathing problems (gasping for air nostrils, flaring when breathing, head bobbed back and forth when breathing), no breathing sound; cough (no coughing, little coughing without problems). Kaplan-Meier method was used for estimation.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=19 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Time From First Study Dose to Resolution of Key RSV Signs/Symptoms Based on Observer Reported Outcome (ObsRO) After Free of Supplementation (Oxygen/Feeding/Hydration) for at Least 24 Hours	237.0 Hours Interval 114.38 to Here, NA indicates that upper limit of 95% confidence interval (CI) could not be estimated due to low number of participants with events.	144.8 Hours Interval 96.09 to 210.93

SECONDARY outcome

Timeframe: Up to Day 35

Population: ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis.

RSV related complications included respiratory complications (respiratory failure, apnoeic attacks, bronchiolitis, bronchial obstruction, pneumonia and asthmatic crisis), infectious complications (otitis media, bacterial respiratory tract infections and sepsis), cardiovascular complications (arrhythmia, cardiogenic shock, hemodynamic instability, congestive cardiac failure), acid-base or electrolyte complications (metabolic acidosis, metabolic alkalosis, hyponatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoglycemia and hyperglycemia). Participants were counted only once, regardless of the number of complications they actually experienced.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=19 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Number of Participants With Post-baseline RSV-related Complications	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 1 up to Day 35

Population: Safety analysis set included all participants who received at least 1 dose of study intervention.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE with an onset after the initiation study drug (Day 1) up to end of study (Day 35). AEs included both serious and non-serious AEs.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=20 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	5 Participants	11 Participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants with available data at each specified category.

Number of participants with abnormally low (AL) and abnormally high (AH) values of bicarbonate, direct bilirubin, urea nitrogen, basophils, eosinophils, erythrocyte (Ery). mean corpuscular hemoglobin (HGB) concentration (conc), Ery. mean corpuscular hemoglobin, erythrocytes, leukocytes, lymphocytes, monocytes, neutrophils and reticulocytes were reported based on the investigator's discretion.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=18 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Number of Participants With Abnormalities in Clinical Laboratory Values Bicarbonate- Abnormally low	1 Participants	3 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Bicarbonate- Abnormally high	0 Participants	0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Direct bilirubin- Abnormally low	2 Participants	9 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Direct bilirubin- Abnormally high	0 Participants	0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Urea nitrogen- Abnormally low	1 Participants	3 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Urea nitrogen- Abnormally high	0 Participants	0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Basophils- Abnormally low	0 Participants	0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Basophils- Abnormally high	0 Participants	1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Eosinophils- Abnormally low	0 Participants	0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Eosinophils- Abnormally high	5 Participants	12 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Ery. mean corpuscular HGB conc.-AL	1 Participants	3 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Ery. mean corpuscular HGB conc.-AH	0 Participants	0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Ery. mean corpuscular hemoglobin-AL	0 Participants	3 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Ery. mean corpuscular hemoglobin-AH	0 Participants	0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Erythrocytes- Abnormally low	0 Participants	0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Erythrocytes- Abnormally high	0 Participants	2 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Leukocytes- Abnormally low	1 Participants	1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Leukocytes- Abnormally high	0 Participants	5 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Lymphocytes- Abnormally low	0 Participants	0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Lymphocytes- Abnormally high	0 Participants	3 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Monocytes- Abnormally low	1 Participants	4 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Monocytes- Abnormally high	0 Participants	0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Neutrophils- Abnormally low	4 Participants	10 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Neutrophils- Abnormally high	0 Participants	0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Reticulocytes- Abnormally low	0 Participants	0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Values Reticulocytes- Abnormally high	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: Safety analysis set included all participants who received at least 1 dose of study intervention.

Number of participants with abnormally low and abnormally high values of ECG parameters (PR interval and RR interval) as assessed based on the investigator's discretion were reported.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=20 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Number of Participants With Abnormalities in Electrocardiograms (ECGs) RR Interval- Abnormally high	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) PR Interval- Abnormally low	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) PR Interval- Abnormally high	0 Participants	1 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) RR Interval- Abnormally low	1 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, 'n' (number analyzed) signifies number of participants with available data at each specified category.

Number of participants with abnormally low and abnormally high values of vital signs from baseline were assessed based on investigator's discretion. Vital signs included systolic blood pressure (SBP) (millimeter of mercury \[mmHg\]), diastolic blood pressure (DBP) (mmHg), pulse rate (beats per minute), respiratory rate (breaths per minute), temperature (degree Celsius) and oxygen saturation (in percentage).

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=20 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Number of Participants With Abnormalities in Vital Signs SBP- Abnormally low	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs SBP- Abnormally high	0 Participants	4 Participants
Number of Participants With Abnormalities in Vital Signs DBP- Abnormally low	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs DBP- Abnormally high	1 Participants	3 Participants
Number of Participants With Abnormalities in Vital Signs Pulse Rate- Abnormally low	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Pulse Rate- Abnormally high	1 Participants	2 Participants
Number of Participants With Abnormalities in Vital Signs Respiratory Rate- Abnormally low	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Respiratory Rate- Abnormally high	0 Participants	3 Participants
Number of Participants With Abnormalities in Vital Signs Temperature - Abnormally low	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Temperature - Abnormally high	1 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Oxygen Saturation- Abnormally low	0 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Oxygen Saturation- Abnormally high	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 35

Percentage of participants requiring ICU stay was analyzed and reported.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=17 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Percentage of Participants Requiring Intensive Care Unit (ICU) Stay After First Dose of Rilematovir	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (Overall number of participants analyzed) signifies participants who required ICU stay before first dose of rilematovir and continued after first dose plus participants who required ICU stay after first dose of drug without prior ICU stay.

Duration (in hours) of ICU stay was defined as total number of hours a participant experienced an ICU stay from first dose of rilematovir until study termination, calculated as the sum of all separate records of ICU stay.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=2 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Duration of ICU Stay	66.46 hours Standard Deviation 24.145 • Interval 24.145 to	40.83 hours Standard Deviation 22.822 • Interval 22.822 to

SECONDARY outcome

Timeframe: Up to Day 35

Population: ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis.

Percentage of participants requiring re-hospitalization (participants re-hospitalized \[ward or ICU\] after been discharged from hospital) for respiratory/other reasons were reported.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=19 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Percentage of Participants Requiring Re-hospitalization for Respiratory/Other Reasons	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 35

Percentage of participants requiring any type of oxygen supplementation (invasive mechanical ventilation, non-invasive mechanical ventilation and non-invasive non-mechanical ventilation) were reported.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=13 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Percentage of Participants Requiring Oxygen Supplementation After First Dose of Rilematovir	16.7 Percentage of participants	30.8 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (Overall number of participants analyzed) signifies participants who required oxygen supplementation before first dose of rilematovir and continued after first dose plus participants who required oxygen supplementation after first dose of rilematovir without prior oxygen supplementation.

Duration (in hours) of oxygen supplementation was defined as total number of hours a participant used supplemental oxygen from either prior to first dose and/or after first dose of drug until study termination, calculated as the sum of all separate records of supplementation.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=10 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Duration of Oxygen Supplementation	39.91 Hours Standard Deviation 26.146 • Interval 26.146 to	66.59 Hours Standard Deviation 51.956 • Interval 51.956 to

SECONDARY outcome

Timeframe: Up to Day 35

Percentage of participants requiring any type of hydration and/or feeding by intravenous (IV) administration or nasogastric tube or percutaneous endoscopic gastrostomy was reported.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=15 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Percentage of Participants Requiring Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube After First Dose of Rilematovir	33.3 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (Overall number of participants analyzed) signifies participants who required supplemental feeding/hydration before first dose of rilematovir and continued after first dose plus participants who required supplemental feeding/hydration after first dose of rilematovir without prior supplemental feeding/hydration.

Duration (in hours) of supplemental feeding/hydration was defined as total number of hours a participant was administered feeding/hydration supplementation from either prior to first dose and/or after first dose of drug until study termination, calculated as the sum all separate records of supplementation use per participant.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=4 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Duration of Supplemental Feeding/Hydration	43.13 Hours Standard Deviation 41.526	31.96 Hours Standard Deviation 21.311

SECONDARY outcome

Timeframe: Up to Day 35

Population: ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis.

Medical resource utilization was assessed by medical care encounters and treatments. Medical encounters and treatments included physician or emergency room visits, tests and procedures, and medications, surgeries and other selected procedures, inpatient and outpatient.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=19 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Number of Participants With Medical Encounters and Treatments	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Days 2, 3, 5, 8, 14 and 21

Antiviral activity was determined based on measurements of RSV viral load which was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in the mid-turbinate (MT) nasal swab specimens.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=19 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
RSV Viral Load at Baseline, Days 2, 3, 5, 8, 14 and 21 Baseline	7.031 log10 copies per milliliter Standard Deviation 1.9995	6.286 log10 copies per milliliter Standard Deviation 1.3671
RSV Viral Load at Baseline, Days 2, 3, 5, 8, 14 and 21 Day 2	6.000 log10 copies per milliliter Standard Deviation 1.5678	5.579 log10 copies per milliliter Standard Deviation 1.5668
RSV Viral Load at Baseline, Days 2, 3, 5, 8, 14 and 21 Day 3	5.465 log10 copies per milliliter Standard Deviation 1.7454	4.981 log10 copies per milliliter Standard Deviation 1.9530
RSV Viral Load at Baseline, Days 2, 3, 5, 8, 14 and 21 Day 5	4.066 log10 copies per milliliter Standard Deviation 1.5565	4.132 log10 copies per milliliter Standard Deviation 1.5199
RSV Viral Load at Baseline, Days 2, 3, 5, 8, 14 and 21 Day 8	1.373 log10 copies per milliliter Standard Deviation 2.0865	2.156 log10 copies per milliliter Standard Deviation 2.1681
RSV Viral Load at Baseline, Days 2, 3, 5, 8, 14 and 21 Day 14	1.217 log10 copies per milliliter Standard Deviation 2.1478	0.709 log10 copies per milliliter Standard Deviation 1.3389
RSV Viral Load at Baseline, Days 2, 3, 5, 8, 14 and 21 Day 21	0.414 log10 copies per milliliter Standard Deviation 1.0961	0.464 log10 copies per milliliter Standard Deviation 1.4547

SECONDARY outcome

Timeframe: Baseline, Days 2, 3, 5, 8, 14 and 21

Population: ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants with data evaluable at each specified time point.

Antiviral activity was determined based on measurements of RSV viral load which was measured by qRT-PCR in the MT nasal swab specimens.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=18 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Change From Baseline in RSV Viral Load at Days 2, 3, 5, 8, 14 and 21 Day 2	-1.031 log10 copies per milliter Standard Deviation 0.6091	-0.825 log10 copies per milliter Standard Deviation 1.2906
Change From Baseline in RSV Viral Load at Days 2, 3, 5, 8, 14 and 21 Day 3	-1.566 log10 copies per milliter Standard Deviation 2.2167	-1.436 log10 copies per milliter Standard Deviation 1.5185
Change From Baseline in RSV Viral Load at Days 2, 3, 5, 8, 14 and 21 Day 5	-2.965 log10 copies per milliter Standard Deviation 1.9154	-2.241 log10 copies per milliter Standard Deviation 1.3393
Change From Baseline in RSV Viral Load at Days 2, 3, 5, 8, 14 and 21 Day 8	-5.658 log10 copies per milliter Standard Deviation 1.9872	-4.126 log10 copies per milliter Standard Deviation 1.8461
Change From Baseline in RSV Viral Load at Days 2, 3, 5, 8, 14 and 21 Day 14	-5.693 log10 copies per milliter Standard Deviation 2.2654	-5.640 log10 copies per milliter Standard Deviation 2.0261
Change From Baseline in RSV Viral Load at Days 2, 3, 5, 8, 14 and 21 Day 21	-7.207 log10 copies per milliter Standard Deviation 1.3201	-5.789 log10 copies per milliter Standard Deviation 1.9560

SECONDARY outcome

Timeframe: Baseline, Days 2, 3, 5, 8, 14 and 21

Percentage of participants with undetectable RSV viral load was analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=19 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Percentage of Participants With Undetectable RSV Viral Load Baseline	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Undetectable RSV Viral Load Day 2	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Undetectable RSV Viral Load Day 3	0 Percentage of Participants	5.3 Percentage of Participants
Percentage of Participants With Undetectable RSV Viral Load Day 5	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Undetectable RSV Viral Load Day 8	62.5 Percentage of Participants	44.4 Percentage of Participants
Percentage of Participants With Undetectable RSV Viral Load Day 14	71.4 Percentage of Participants	76.5 Percentage of Participants
Percentage of Participants With Undetectable RSV Viral Load Day 21	85.7 Percentage of Participants	88.2 Percentage of Participants

SECONDARY outcome

Timeframe: 1 hour Post-dose (Day 1) and pre-dose (Day 2)

Population: Pharmacokinetics analysis set (PKAS) included participants who had received at least 1 dose of rilematovir and had at least 1 valid blood sample drawn for pharmacokinetics analysis. No summary analysis was done as study was terminated early and participant wise data were reported. Here, "n" (Number analyzed) signifies specific participant with data evaluable at each specified timepoint.

Plasma concentrations of rilematovir were assessed. Participant wise data were reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Plasma Concentrations of Rilematovir Participant 3 Day 1	72.5 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 4 Day 1	656 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 5 Day 1	918 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 6 Day 1	1050 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 7 Day 1	135 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 8 Day 1	1730 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 9 Day 1	602 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 10 Day 1	1810 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 9 Day 2	186 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 10 Day 2	687 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 11 Day 2	1750 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 12 Day 2	4650 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 13 Day 2	311 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 14 Day 2	77.3 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 1 Day 1	1450 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 2 Day 1	1750 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 11 Day 1	1640 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 12 Day 1	3760 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 13 Day 1	561 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 14 Day 1	127 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 15 Day 1	787 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 16 Day 1	2020 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 17 Day 1	157 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 18 Day 1	1260 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 1 Day 2	134 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 2 Day 2	281 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 3 Day 2	5.74 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 5 Day 2	417 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 6 Day 2	828 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 7 Day 2	1030 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 8 Day 2	339 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 15 Day 2	749 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 16 Day 2	457 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 17 Day 2	493 nanogram per milliliter	—
Plasma Concentrations of Rilematovir Participant 18 Day 2	2930 nanogram per milliliter	—

SECONDARY outcome

Timeframe: Day 8

Acceptability and palatability were assessed by clinician electronic clinical outcome assessment (eCOA) questionnaire which consisted of 7 questions, 1- child took medicine easily, 2- disgusted expressions after tasting medicine, 3- cried after tasting medicine, 4- would not open mouth or turned head away to avoid medicine, 5- spit out or coughed out medicine, 6- gagged, 7- vomited (within 2 minutes of swallowing medicine).

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=15 Participants Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Percentage of Participants With Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s) Child took medicine easily	85.7 Percentage of participants	86.7 Percentage of participants
Percentage of Participants With Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s) Disgusted expressions after tasting medicine	0 Percentage of participants	13.3 Percentage of participants
Percentage of Participants With Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s) Did not open mouth or turned head away	14.3 Percentage of participants	6.7 Percentage of participants
Percentage of Participants With Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s) Spit out or coughed out medicine	14.3 Percentage of participants	0 Percentage of participants
Percentage of Participants With Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s) Gagged	0 Percentage of participants	6.7 Percentage of participants
Percentage of Participants With Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s) Vomited (within 2 minutes of swallowing medicine)	0 Percentage of participants	0 Percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Rilematovir

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=8 participants at risk Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=20 participants at risk Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Infections and infestations Parainfluenzae Virus Infection	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.

Other adverse events

Additional Information

Senior Director Medical Leader

Janssen Research & Development LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=8 participants at risk Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).	Rilematovir n=20 participants at risk Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
Blood and lymphatic system disorders Neutrophilia	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Thrombocytosis	12.5% 1/8 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	10.0% 2/20 • Number of events 2 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal Pain	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Faeces Discoloured	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Number of events 2 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	0.00% 0/20 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
General disorders Hyperthermia	12.5% 1/8 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	0.00% 0/20 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
General disorders Infusion Site Extravasation	12.5% 1/8 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	0.00% 0/20 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
General disorders Pyrexia	12.5% 1/8 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	10.0% 2/20 • Number of events 2 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Infections and infestations Covid-19	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Infections and infestations Laryngitis	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Infections and infestations Pneumonia	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Infections and infestations Rhinitis	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 2 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Investigations Blood Magnesium Decreased	12.5% 1/8 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	0.00% 0/20 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Investigations Eosinophil Count Increased	12.5% 1/8 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	0.00% 0/20 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Investigations Oxygen Saturation Decreased	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Nervous system disorders Headache	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	10.0% 2/20 • Number of events 2 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Eczema Infantile	12.5% 1/8 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	0.00% 0/20 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Skin Exfoliation	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/8 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to Day 35 Safety analysis set included all participants who received at least 1 dose of study intervention.