CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
Palivizumab +2 moredrug
Likely dose
Palivizumab 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04540627
NCT04540627Phase 1Completed
CompareCT.gov

A Double-Blind, Randomised, Placebo-Controlled Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With Respiratory Syncytial Virus (RSV)

mAbxience Research S.L.·interventional·Posted Sep 7, 2020·Updated Oct 4, 2021

In Brief

A Phase 1 clinical trial evaluating Palivizumab, Placebo, and 1 other intervention for Healthy Adult Participants. Completed, enrolled 56 participants across 1 site.

Detailed Summary

Double-Blind, Randomised, Placebo-Controlled Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated with Respiratory Syncytial Virus (RSV).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adult Participants
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedSep 7, 2020
Enrollment StartJul 6, 2020
Primary CompletionOct 23, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.8 years ago

Interventions

Palivizumabdrug

Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg or 15mg/kg, administered at a rate of 1mL/min

Placebodrug

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 virusother

Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)