Trial Outcomes & Findings for Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With RSV (NCT NCT04540627)

NCT ID: NCT04540627

Last Updated: 2021-10-04

Results Overview

The PK assessment up to and including Day 12 exposure was used as a decision information for the dose to be given to participants in Part 2. Pharmacokinetic exposure data from at least 5 out of 6 participants were required for dose decision making with a projected exposure of ≥40 μg/mL on Day 12 according to the protocol. This was achieved after administration of a single IV dose of Palivizumab at 8 mg/kg. Therefore, a dose of 8 mg/kg was chosen for Part 2.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 56 participants
• Primary outcome timeframe: In Part 1: before the start of infusion; at end of infusion,15 minutes and 0.5, 1, 4, 8, and 12 hours after infusion; and at 1, 2, 3, 7, and 12 days after infusion.
• Results posted on: 2021-10-04

Participant Flow

The study was conducted in 2 parts: Part 1 (PK sentinel part) and Part 2 (viral challenge part). Part 1: Open-label. This part of the study was used to determine the dose of Palivizumab IV for Part 2 (8 or 15 mg/kg). Part 2: Double-blind, randomized, and placebo-controlled. Participants received a single IV dose of either Palivizumab (8 mg/kg, as finally determined in Part 1) or a placebo and were subsequently challenged with an RSV-A strain.

Participant milestones

Measure	Open-label Palivizumab (Part 1) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Open-label Treatment: PK Sentinel STARTED	6	0	0
Open-label Treatment: PK Sentinel COMPLETED	6	0	0
Open-label Treatment: PK Sentinel NOT COMPLETED	0	0	0
Double-blind Treatment: Viral Challenge STARTED	0	25	25
Double-blind Treatment: Viral Challenge COMPLETED	0	25	25
Double-blind Treatment: Viral Challenge NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With RSV

Baseline characteristics by cohort

Measure	Open-label Palivizumab (Part 1) n=6 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=25 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Total n=56 Participants Total of all reporting groups
Age, Continuous	25.67 years STANDARD_DEVIATION 2.58 • n=5 Participants	28.16 years STANDARD_DEVIATION 6.30 • n=7 Participants	26.76 years STANDARD_DEVIATION 5.83 • n=5 Participants	26.86 years STANDARD_DEVIATION 4.90 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	12 Participants n=7 Participants	5 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants	37 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	23 Participants n=7 Participants	20 Participants n=5 Participants	47 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 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

PRIMARY outcome

Timeframe: In Part 1: before the start of infusion; at end of infusion,15 minutes and 0.5, 1, 4, 8, and 12 hours after infusion; and at 1, 2, 3, 7, and 12 days after infusion.

Population: All participants treated had at least 1 post-dose PK result; therefore, all participants were included in the PK analysis population. One participant had an interrupted IV infusion of Palivizumab but received the complete dose of 8 mg/kg.

The PK assessment up to and including Day 12 exposure was used as a decision information for the dose to be given to participants in Part 2. Pharmacokinetic exposure data from at least 5 out of 6 participants were required for dose decision making with a projected exposure of ≥40 μg/mL on Day 12 according to the protocol.

This was achieved after administration of a single IV dose of Palivizumab at 8 mg/kg. Therefore, a dose of 8 mg/kg was chosen for Part 2.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=6 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Mean Serum Concentrations (Cmax) for Open-label Palivizumab (Part 1) on Day 12.	71.2 μg/mL Standard Deviation 6.11	—	—

PRIMARY outcome

Timeframe: From two days post viral challenge (Day 2) to the end of quarantine (Day 12) in Part 2 on nasal samples collected twice daily.

Population: The evaluable population includes 49 participants. All participants in this population received study intervention, were inoculated with challenge virus, and completed quarantine. One Palivizumab-treated participant was excluded from the evaluable population because the participant had not completed the quarantine period.

RSV viral load of RSV-A Memphis 37b as determined by qRT-PCR on nasal samples collected twice daily: Assessment of the Area under the viral load-time curve (VL-AUC)

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Area Under the Viral Load-time Curve (VL-AUC) as Determined by Polymerase Chain Reaction (qRT-PCR) on Nasal Samples, for Double-blind Palivizumab or Placebo (Part 2).	11.68 Log10 copies*day/mL Standard Deviation 15.36	9.94 Log10 copies*day/mL Standard Deviation 12.38	—

PRIMARY outcome

Timeframe: From two days post viral challenge (Day 2) to the end of quarantine (Day 12) in Part 2

Population: The evaluable population includes 49 participants. All participants in this population received study intervention, were inoculated with challenge virus, and completed quarantine. One Palivizumab-treated participant was excluded from the evaluable population because the participant had not completed the quarantine period.

Peak viral load of RSV-A Memphis 37b as determined by qRT-PCR on nasal samples collected twice daily.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
qRT-PCR Peak Viral Load for Double-blind Palivizumab or Placebo (Part 2).	3.66 Log10 copies/mL Standard Deviation 2.42	3.11 Log10 copies/mL Standard Deviation 2.65	—

SECONDARY outcome

Timeframe: From two days post viral challenge (Day 2) to the end of quarantine (Day 12) in Part 2 on nasal samples collected twice daily.

Population: Evaluable population

RSV Viral Load of RSV-A Memphis 37b as Determined by Cell Culture on Nasal Samples collected twice daily: Area under the viral load-time curve (VL-AUC) of RSV-A Memphis 37b

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=22 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=22 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Area Under the Viral Load-time Curve (VL-AUC) as Determined by Cell Culture on Nasal Samples, for Double-blind Palivizumab (Part 2).	2.05 Log10 PFU*day/mL Standard Deviation 5.29	1.64 Log10 PFU*day/mL Standard Deviation 3.43	—

SECONDARY outcome

Timeframe: From Day 2 to Day 12 in Part 2

Population: Evaluable population

Peak Viral Load of RSV-A Memphis 37b as Determined by Cell Culture on Nasal Sample

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Cell Culture Peak Viral Load for Double-blind Palivizumab or Placebo (Part 2).	0.60 Log10 PFU/mL Standard Deviation 1.47	0.88 Log10 PFU/mL Standard Deviation 1.41	—

SECONDARY outcome

Timeframe: From Day 2 to Day 12 in Part 2

Percentage of Participants Infected Post-viral Challenge (Infectivity Status and Rate): occurrence of at least 2 positive "quantifiable" qRT-PCR measurements in nasal samples.

Laboratory-confirmed infection (variant 1): At least 2 positive quantifiable detections by viral load qRT-PCR assay specific for the challenge virus, reported within 4 consecutive scheduled assessments and from 2 independent samples from Day 2 until discharge and/or 1 positive detection by viral load qRT-PCR assay, specific for the challenge virus, in which an aliquot of the same sample has also tested positive in a viral culture assay appropriate for detecting the challenge virus from Day 2 until discharge.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Number of Participants With Laboratory-confirmed Infection of RSV-A Memphis 37b in Nasal Samples (Variant 1) for Double-blind Palivizumab or Placebo (Part 2).	13 Participants	12 Participants	—

SECONDARY outcome

Timeframe: From Day 2 to Day 12 in Part 2

Percentage of Participants Infected Post-viral Challenge (Infectivity Status and Rate): Occurrence of at least 2 positive "detectable" qRT-PCR measurements in nasal samples.

Laboratory-confirmed infection (variant 2): At least 2 positive detectable assessments by viral load qRT-PCR assay specific for the challenge virus, reported within 4 consecutive scheduled assessments and from 2 independent samples from Day 2 until discharge and/or 1 positive detection by viral load qRT-PCR assay, specific for the challenge virus, in which an aliquot of the same sample has also tested positive in a viral culture assay appropriate for detecting the challenge virus from Day 2 until discharge.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Number of Participants With Laboratory-confirmed Infection of RSV-A Memphis 37b in Nasal Samples (Variant 2), for Double-blind Palivizumab or Placebo (Part 2).	15 Participants	15 Participants	—

SECONDARY outcome

Timeframe: From Day 2 to Day 12 in Part 2

Population: Evaluable population

Estimation of the duration of viral shedding by the number of days with quantifiable qRT-PCR measurements in nasal samples starting 2 days post viral challenge (Day 2) up to the end of quarantine.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=23 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Viral Shedding of RSV-A Memphis 37b in Nasal Samples in Terms of Duration, for Double-blind Palivizumab or Placebo (Part 2).	2.84 days Standard Deviation 3.01	2.61 days Standard Deviation 2.98	—

SECONDARY outcome

Timeframe: From Day 2 to Day 12 in Part 2

Population: Evaluable population

Estimation of the duration of viral shedding by the time to peak viral load of RSV by quantifiable qRT-PCR.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=22 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=16 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Viral Shedding of RSV-A Memphis 37b in Nasal Samples in Terms of Time to Peak Viral Load, for Double-blind Palivizumab or Placebo (Part 2).	7.21 days Standard Deviation 2.98	7.03 days Standard Deviation 2.35	—

SECONDARY outcome

Timeframe: From Day 2 to Day 12 in Part 2

Population: Evaluable population

Peak viral load of RSV-A Memphis 37b as defined by the maximum viral load determined by quantifiable qRT PCR measurements in nasal samples starting 2 days post viral challenge (Day 2) up to the end of quarantine.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Viral Shedding of RSV-A Memphis 37b in Nasal Samples in Terms of Peak Viral Load, for Double-blind Palivizumab or Placebo (Part 2).	3.66 Log10 copies/mL Standard Deviation 2.42	3.11 Log10 copies/mL Standard Deviation 2.65	—

SECONDARY outcome

Timeframe: From two days post viral challenge (Day 2) to the end of quarantine (Day 12) in Part 2 on nasal samples collected twice daily.

Population: Evaluable population

Mean TSS values (collected daily in the symptom diary card) over time. Symptoms were collected using the hVIVO (services provider) symptom diary card. Several symptoms (such as runny nose, sore throat, earache, etc) in the 13-item questionnaire were graded on a scale of 0-3 (grade 0: No symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: Quite bothersome most or all of the time, and it stops me participating in activities). Shortness of breath and wheeze have an additional grade 4: Symptoms at rest. The total symptom score (TSS) was determined as the sum of the symptom scores ranging from 0.0 (min) to 41(max) [or a maximum of 41x11.33=464.67 depending on what the reviewer is asking] using a 13-items self-reported diary card. 11.33 is the number of days symptom diary cards were included (Day +1 morning dairy card to Day 12 morning diary card). Higher scores mean worse outcome.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Total Symptom Score (TSS)-Time Curve (AUC) Collected Daily in the Participant Symptom Diary Card	13.84 Total Symptom Score scale-points*day Standard Error 14.72	7.27 Total Symptom Score scale-points*day Standard Error 9.03	—

SECONDARY outcome

Timeframe: From Day 2 to Day 12 in Part 2

Population: Evaluable population

Peak symptom scores for symptoms collected daily in the participant symptom diary card.

Symptoms (such as runny nose, sore throat, earache, etc) were collected using the 13-item hVIVO symptom questionnaire and were graded on a scale of 0-3 (grade 0: No symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: Quite bothersome most or all of the time, and it stops me participating in activities). Shortness of breath and wheeze have an additional grade 4: Symptoms at rest. The total symptom score (TSS) was determined as the sum of the symptom scores ranging from 0.0 (min) to 41(max) [or a maximum of 41x11.33=464.67 depending on what the reviewer is asking] using a 13-items self-reported diary card. 11.33 is the number of days symptom diary cards were included (Day +1 morning dairy card to Day 12 morning diary card). Higher scores mean worse outcome.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Peak Symptom Scores	4.16 score on a scale Standard Error 3.45	2.54 score on a scale Standard Error 3.32	—

SECONDARY outcome

Timeframe: From Day 1 to Day 12 in Part 2

Population: Evaluable population

Nasal Discharge Collection from Paper Tissues by means of the total weight of nasal discharge produced.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=23 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=21 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Total Weight of Nasal Discharge Produced	22.23 g Standard Error 41.52	7.66 g Standard Error 14.92	—

SECONDARY outcome

Timeframe: From Day 1 to Day 12 in Part 2

Population: Evaluable population

Nasal Discharge Collection from Paper Tissues by means of the total number of tissues used.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Total Number of Tissues Used by Participants	32.04 tissues Standard Error 42.74	20.38 tissues Standard Error 21.88	—

SECONDARY outcome

Timeframe: From Day 2 to Day 12 in Part 2

Illness Post-viral challenge measured by means of the proportion of participants with any symptom ≥grade 1 for the evaluable population.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Number of Participants With Laboratory-confirmed Virus-like Illness (Variant 1) Using Viral Shedding Variant 1, for Double-blind Palivizumab or Placebo (Part 2).	11 Participants	5 Participants	—

SECONDARY outcome

Timeframe: From Day 2 to Day 12 in Part 2

Illness Post-viral challenge measured by means of the proportion of participants with any symptom ≥grade 1 for the evaluable population.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
The Occurrence of Laboratory-confirmed Virus-like Illness (Variant 1) Using Viral Shedding Variant 2, for Double-blind Palivizumab or Placebo (Part 2).	11 Participants	5 Participants	—

SECONDARY outcome

Timeframe: From Day 2 to Day 12 in Part 2

Illness Post-viral challenge measured by means of the proportion of participants with any symptom ≥grade 1 for the evaluable population.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
The Occurrence of Laboratory-confirmed Virus-like Illness (Variant 2) Using Viral Shedding Variant 1, for Double-blind Palivizumab or Placebo (Part 2).	13 Participants	11 Participants	—

SECONDARY outcome

Timeframe: From Day 2 to Day 12 in Part 2

Illness Post-viral challenge measured by means of the proportion of participants with any symptom ≥grade 1 for the evaluable population.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=24 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
The Occurrence of Laboratory-confirmed Virus-like Illness (Variant 2) Using Viral Shedding Variant 2, for Double-blind Palivizumab or Placebo (Part 2).	15 Participants	14 Participants	—

SECONDARY outcome

Timeframe: Before the start of infusion; at end of infusion, 15 minutes and 0.5, 1, 4, 8, and 12 hours after infusion; and at 1, 2, 3, 7 and 12 days after infusion (Part 1) or at 1, 2, 3, 7, 13, 21, and 29 days after infusion (Part 2)

Population: All participants treated had at least 1 post-dose PK result; therefore, all participants were included in the PK analysis population. One participant had an interrupted IV infusion of Palivizumab but received the complete dose of 8 mg/kg.

Evaluation of Palivizumab PK levels throughout the study, by means of Cmax after intravenous administration of Palivizumab.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=5 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) n=23 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Cmax	262 μg/mL Standard Deviation 35.6	—	283 μg/mL Standard Deviation 46.5

SECONDARY outcome

Timeframe: Before the start of infusion; at end of infusion, 15 minutes and 0.5, 1, 4, 8, and 12 hours after infusion; and at 1, 2, 3, 7, and 12 days after infusion (Part 1) or at 1, 2, 3, 7, 13, 21, and 29 days after infusion (Part 2)

Population: All participants treated had at least 1 post-dose PK result; therefore, all participants were included in the PK analysis population. One participant had an interrupted IV infusion of Palivizumab but received the complete dose of 8 mg/kg.

Palivizumab PK levels throughout the study, by means of Tmax after intravenous administration of Palivizumab.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=5 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) n=23 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Tmax	0.90 hours Interval 0.57 to 1.7	—	0.92 hours Interval 0.53 to 1.77

SECONDARY outcome

Timeframe: From Day 1 to Day 18 in Part 1 and from Day 1 to Day 28 in Part 2

Population: Safety analysis population: All participants randomly assigned to study intervention and who took a dose of study intervention, regardless of whether they received the challenge virus or not.

Incidence of AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs) and; drug-related or challenge-virus related TEAEs and SAEs

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=6 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) n=25 Participants Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Safety Adults: Number of Participants With Adverse Events (AEs) Any AE	0 participants	12 participants	14 participants
Safety Adults: Number of Participants With Adverse Events (AEs) Any SAE related to the challenge virus	0 participants	0 participants	1 participants
Safety Adults: Number of Participants With Adverse Events (AEs) Any death	0 participants	0 participants	0 participants
Safety Adults: Number of Participants With Adverse Events (AEs) Any TEAE	0 participants	12 participants	14 participants
Safety Adults: Number of Participants With Adverse Events (AEs) Any TEAE related to the study drug	0 participants	1 participants	4 participants
Safety Adults: Number of Participants With Adverse Events (AEs) Any TEAE related to the challenge virus	0 participants	5 participants	8 participants
Safety Adults: Number of Participants With Adverse Events (AEs) Any SAE	0 participants	0 participants	1 participants
Safety Adults: Number of Participants With Adverse Events (AEs) Any SAE leading to study discontinuation	0 participants	0 participants	0 participants
Safety Adults: Number of Participants With Adverse Events (AEs) Any SAE related to the study treatment	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Part 2: prior to infusion with Palivizumab and 7, 13, and 29 days post Palivizumab infusion.

Population: Safety analysis population: All participants randomly assigned to study intervention and who took a dose of study intervention, regardless of whether they received the challenge virus or not.

Determination of the incidence of anti-palivizumab ADA (number and percent of participants tested positive for anti-palivizumab ADA). ADA positive participant: baseline negative and any sample after treatment positive, or baseline positive and titre increased 4- to 9-fold after treatment) before the dose of palivizumab and at scheduled post-dose assessments.

Outcome measures

Measure	Open-label Palivizumab (Part 1) n=25 Participants Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min	Double-blind Placebo (Part 2) Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Immunogenicity: Number of Participants Positive for Anti-palivizumab Antibody (ADA)	0 Participants	—	—

Adverse Events

Double-blind Placebo (Part 2)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Double-blind Palivizumab (Synagis™) (Part 2)

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Double-blind Placebo (Part 2) n=25 participants at risk Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) n=25 participants at risk Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Cardiac disorders Myocarditis	0.00% 0/25 • Day 1 to Day 28 Adverse events were coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class, preferred term, and treatment group for the number of AEs reported and the number and percentage of patients reporting each AE.	4.0% 1/25 • Number of events 1 • Day 1 to Day 28 Adverse events were coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class, preferred term, and treatment group for the number of AEs reported and the number and percentage of patients reporting each AE.

Other adverse events

Measure	Double-blind Placebo (Part 2) n=25 participants at risk Sodium Chloride 0.9% Solution (Normal Saline) Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)	Double-blind Palivizumab (Synagis™) (Part 2) n=25 participants at risk Sterile vial 50mg/0.5mL Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Investigations Alanine Aminotransferase Increased	24.0% 6/25 • Number of events 6 • Day 1 to Day 28 Adverse events were coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class, preferred term, and treatment group for the number of AEs reported and the number and percentage of patients reporting each AE.	36.0% 9/25 • Number of events 9 • Day 1 to Day 28 Adverse events were coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class, preferred term, and treatment group for the number of AEs reported and the number and percentage of patients reporting each AE.
Investigations Aspartate aminotransferase increased	16.0% 4/25 • Number of events 4 • Day 1 to Day 28 Adverse events were coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class, preferred term, and treatment group for the number of AEs reported and the number and percentage of patients reporting each AE.	20.0% 5/25 • Number of events 5 • Day 1 to Day 28 Adverse events were coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class, preferred term, and treatment group for the number of AEs reported and the number and percentage of patients reporting each AE.
Skin and subcutaneous tissue disorders Rash	0.00% 0/25 • Day 1 to Day 28 Adverse events were coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class, preferred term, and treatment group for the number of AEs reported and the number and percentage of patients reporting each AE.	8.0% 2/25 • Number of events 2 • Day 1 to Day 28 Adverse events were coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class, preferred term, and treatment group for the number of AEs reported and the number and percentage of patients reporting each AE.
Musculoskeletal and connective tissue disorders Back Pain	8.0% 2/25 • Number of events 2 • Day 1 to Day 28 Adverse events were coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class, preferred term, and treatment group for the number of AEs reported and the number and percentage of patients reporting each AE.	0.00% 0/25 • Day 1 to Day 28 Adverse events were coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class, preferred term, and treatment group for the number of AEs reported and the number and percentage of patients reporting each AE.

Additional Information

Director of Clinical Trials

mAbxience Research SL

Phone: +34917711500

Email: susana.millan@mabxience.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is \>60 days but \< or= 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication if it does not include any reference to the Sponsor, any Study Identifier, or any Property or other Confidential Information of the Sponsor, other than the anonymized Non-drug data.
• Publication restrictions are in place

Restriction type: OTHER