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OpenTrials
Completed

NCT Number: NCT03258502

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

hVIVO Services Ltd

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 45 years, inclusive
  • In good health with no history of major medical conditions
  • A total body weight ≥ 50 kg and a body mass index (BMI) of >/=18kg/m2 and </=30kg/m2

Exclusion criteria

  • Evidence of any clinically significant or currently active major medical condition
  • Positive for Human Immunodeficiency Virus, active Hepatitis A, B or C test
  • Significant nose or nasopharynx abnormalities
  • Abnormal lung function
  • History or currently active symptoms suggestive of upper or lower respiratory tract infection

Treatment and study plan

RV521

Drug

RV521 drug in capsules

Placebo

Drug

Placebo in capsules

Primary outcomes

  1. Change in viral load

    Time frame: Baseline to study day 12

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 23, 2017
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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