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A RANDOMISED, PHASE 1B, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RV299 AGAINST RESPIRATORY SYNCYTIAL VIRUS IN THE VIRAL CHALLENGE MODEL
The purpose of the study is to learn about the safety, pharmacokinetics and antiviral activity of the study medicine (RV299) for the potential treatment of respiratory syncytial virus (RSV). RSV is a highly contagious virus that can lead to serious lung infections in patients with reduced ability to fight infection. Most vulnerable populations include babies, the elderly and patients that have received a bone marrow transplant.
This study is seeking healthy participants who are: Healthy adult male and female participants aged between 18 to 55 years, with a total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2 and who have been screened to be sero-suitable for infection with the RSV-A Memphis 37b virus challenge virus. A total of 80 participants is planned: 40 participants on RV299 and 40 participants on placebo. The study is divided into 3 phases: * Screening phase: from Day -90 to Day-3 pre-human viral challenge (HVC). * Inpatient phase: Participants will be resident in the quarantine unit for approximately 15 days (from Day -2 to Day 12). * Post RSV-A Memphis 37b virus inoculation on Day 0, participants will be randomized to receive RV299 or matched placebo. * Administration of RV299 or placebo will be twice daily (\~12 hours interval) for 5 consecutive days and will start on confirmation of RSV infection. * Outpatient phase: Day 28 (±3 days)
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Pfizer
London, United Kingdom
Start Date
August 8, 2022
Primary Completion Date
December 2, 2022
Completion Date
December 2, 2022
Last Updated
October 21, 2024
82
ACTUAL participants
RV299
DRUG
Placebo
DRUG
Lead Sponsor
Pfizer
NCT05045612
NCT06998251
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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