Trial Outcomes & Findings for A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV (NCT NCT06102174)

Last Updated: 2025-12-30

Results Overview

An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. All AEs were included for evaluation.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)

Results posted on

2025-12-30

Participant Flow

As per plan study was to have 3 cohorts: 1, 2, and 3. Cohorts 1 and 2 was to have further 4 sub-cohorts: A, B, C and D; and Cohort 3 to have sub-cohorts: B, D, E and F. However, due to early termination of study participants were enrolled only in Cohorts 1A, 1B and 1C. No participants were enrolled in Cohort 1D, Cohort 2, and in Cohort 3; hence no results are reported for them. All results are only pertaining to Cohorts 1A, 1B and 1C in this record.

In this study, participants aged from 1 day to \<=60 months received study intervention. Participants of Cohort 1A received study intervention at a low dose level and participants of Cohorts 1B and 1C received study treatment at high dose levels. Cohort 1A had participants of age category 1 (the lowest age category), cohort 1B had participants of age category 2 (medium age category) and cohort 1C had participants of age category 3 (the highest age category).

Participant milestones

Participant milestones
Measure	Cohort 1A: Sisunatovir Participants of age category 1 were randomized and sisunatovir was administered at low dose level orally or via nasogastric tube for 5 days.	Cohort 1A: Placebo Participants of age category 1 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1B: Sisunatovir Participants of age category 2 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.	Cohort 1B: Placebo Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1C: Sisunatovir Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.	Cohort 1C: Placebo Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.
Overall Study STARTED	1	1	2	1	3	2
Overall Study COMPLETED	1	1	2	1	3	2
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1A: Sisunatovir n=1 Participants Participants of age category 1 were randomized and sisunatovir was administered at low dose level orally or via nasogastric tube for 5 days.	Cohort 1A: Placebo n=1 Participants Participants of age category 1 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1B: Sisunatovir n=2 Participants Participants of age category 2 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.	Cohort 1B: Placebo n=1 Participants Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1C: Sisunatovir n=3 Participants Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.	Cohort 1C: Placebo n=2 Participants Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=174 Participants	1 Participants n=166 Participants	2 Participants n=167 Participants	1 Participants n=164 Participants	3 Participants n=671 Participants	2 Participants n=77 Participants	10 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants	0 Participants n=671 Participants	0 Participants n=77 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants	0 Participants n=671 Participants	0 Participants n=77 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=174 Participants	0 Participants n=166 Participants	1 Participants n=167 Participants	0 Participants n=164 Participants	1 Participants n=671 Participants	2 Participants n=77 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=174 Participants	1 Participants n=166 Participants	1 Participants n=167 Participants	1 Participants n=164 Participants	2 Participants n=671 Participants	0 Participants n=77 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants	1 Participants n=671 Participants	0 Participants n=77 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=174 Participants	1 Participants n=166 Participants	2 Participants n=167 Participants	1 Participants n=164 Participants	2 Participants n=671 Participants	2 Participants n=77 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants	0 Participants n=671 Participants	0 Participants n=77 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants	0 Participants n=671 Participants	0 Participants n=77 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=174 Participants	1 Participants n=166 Participants	2 Participants n=167 Participants	1 Participants n=164 Participants	2 Participants n=671 Participants	2 Participants n=77 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants	1 Participants n=671 Participants	0 Participants n=77 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants	0 Participants n=671 Participants	0 Participants n=77 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	1 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants	0 Participants n=671 Participants	0 Participants n=77 Participants	1 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants	0 Participants n=671 Participants	0 Participants n=77 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants	0 Participants n=671 Participants	0 Participants n=77 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)

Population: Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Outcome measures

Outcome measures
Measure	Cohort 1C: Placebo n=2 Participants Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1A: Sisunatovir n=1 Participants Participants of age category 1 were randomized and sisunatovir was administered at low dose level orally or via nasogastric tube for 5 days.	Cohort 1A: Placebo n=1 Participants Participants of age category 1 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1B: Sisunatovir n=2 Participants Participants of age category 2 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.	Cohort 1B: Placebo n=1 Participants Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1C: Sisunatovir n=3 Participants Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	3 Participants

PRIMARY outcome

Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)

Population: Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs.

Outcome measures

Outcome measures
Measure	Cohort 1C: Placebo n=2 Participants Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1A: Sisunatovir n=1 Participants Participants of age category 1 were randomized and sisunatovir was administered at low dose level orally or via nasogastric tube for 5 days.	Cohort 1A: Placebo n=1 Participants Participants of age category 1 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1B: Sisunatovir n=2 Participants Participants of age category 2 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.	Cohort 1B: Placebo n=1 Participants Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1C: Sisunatovir n=3 Participants Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.
Number of Participants Who Discontinued From Study Due to TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)

Population: Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. A serious AE (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening experience (immediate risk of death); required inpatient hospitalization or prolongation if existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; other important event or situation as pre-specified in protocol.

Outcome measures

Outcome measures
Measure	Cohort 1C: Placebo n=2 Participants Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1A: Sisunatovir n=1 Participants Participants of age category 1 were randomized and sisunatovir was administered at low dose level orally or via nasogastric tube for 5 days.	Cohort 1A: Placebo n=1 Participants Participants of age category 1 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1B: Sisunatovir n=2 Participants Participants of age category 2 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.	Cohort 1B: Placebo n=1 Participants Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1C: Sisunatovir n=3 Participants Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.
Number of Participants Who Discontinued From Study Due to Serious TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)

Population: Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, mean cell volume, mean cell hemoglobin \& concentration); chemistry: urea and creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyl transferase (GGT), calcium, sodium, potassium, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase, albumin, total protein, cystatin C; urinalysis: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, albumin, creatinine (urine), urine albumin to creatinine ratio. Clinically significant laboratory abnormalities findings were based on investigator discretion.

Outcome measures

Outcome measures
Measure	Cohort 1C: Placebo n=2 Participants Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1A: Sisunatovir n=1 Participants Participants of age category 1 were randomized and sisunatovir was administered at low dose level orally or via nasogastric tube for 5 days.	Cohort 1A: Placebo n=1 Participants Participants of age category 1 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1B: Sisunatovir n=2 Participants Participants of age category 2 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.	Cohort 1B: Placebo n=1 Participants Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1C: Sisunatovir n=3 Participants Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.
Number of Participants With Clinically Significant Laboratory Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)

Population: Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Vital signs included systolic and diastolic blood pressure, pulse rate/heart rate, temperature, respiratory rate, and oxygen saturation. Clinically significance vital signs findings were based on investigator discretion.

Outcome measures

Outcome measures
Measure	Cohort 1C: Placebo n=2 Participants Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1A: Sisunatovir n=1 Participants Participants of age category 1 were randomized and sisunatovir was administered at low dose level orally or via nasogastric tube for 5 days.	Cohort 1A: Placebo n=1 Participants Participants of age category 1 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1B: Sisunatovir n=2 Participants Participants of age category 2 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.	Cohort 1B: Placebo n=1 Participants Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.	Cohort 1C: Sisunatovir n=3 Participants Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days.
Number of Participants With Clinically Significant Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 3: Pre-dose, T1 and T2 hours post-dose; Day 5: Pre-dose; where T1 is the first analysis time point post-dose while T2 is the second analysis time point post-dose

Population: Pharmacokinetic (PK) concentration set: all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 concentration value can be reported. "Number Analyzed": participants evaluable for specified timepoints, if its value is 0 it means data was missing, PK concentration was not collected at respective timepoint and arm. Data was analyzed and reported only for those arms where participants took sisunatovir, not for placebo arms.