NCT03258502

A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection

A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Pharmacokinetics And Antiviral Activity Of Multiple Doses Of RV521 Against Respiratory Syncytial Virus Infection In The Virus Challenge Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to learn about the safety, pharmacokinetics and antiviral activity of the study medicine (called sisunatovir/RV521) for the potential treatment of respiratory syncytial virus (RSV). Sisunatovir will be given as multiple doses during the treatment period. 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: 1. Aged 18 to 45 years old and will agree to the use of highly effective methods of contraception. 2. with a body mass index (BMI) of 18.0 to 30.0 Kg/m2 This study will consist of 2 cohorts of 33 participants each. In both cohorts participants will be exposed to the challenge virus on study day 0. Cohort 1 will receive either 200 mg of sisunatovir or placebo (looks the same as sisunatovir but contains no active medicine) 2 times a day for 5 days. Cohort 2 will receive either 350 mg of sisunatovir or placebo 2 times a day for 5 days. Participants will start taking the study medicine upon confirmation of RSV infection (or evening of Day 5 if not positive to RSV). The study medicine will be administered 12 hours apart (or twice daily). Each participant will remain in the quarantine unit until discharge on Day 12.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	RV521	RV521 drug in capsules
DRUG	Placebo	Placebo in capsules

Timeline

• Start date: 2017-07-19
• Primary completion: 2017-10-31
• Completion: 2017-10-31
• First posted: 2017-08-23
• Last updated: 2025-07-31

Locations

1 site across 1 country: United Kingdom