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

NCT03258502 | Completed Phase 2

• 2 other identifiers: REVC002C5241002
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 1.Aged 18 to 45 years old and will agree to the use of highly effective methods of contraception.
2. 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

Outcome Measures

Primary Outcomes (1)

• Change in viral load

  Baseline to study day 12

Study Arms (2)

RV521

EXPERIMENTAL

RV521 drug substance in capsule for oral administration

Drug: RV521

Placebo

PLACEBO COMPARATOR

Micro-crystalline cellulose in capsule for oral administration

Drug: Placebo

Interventions

RV521 DRUG

RV521 drug in capsules

RV521

Placebo DRUG

Placebo in capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

hVIVO Services Ltd

London, United Kingdom

Location

Related Publications (1)

• DeVincenzo J, Tait D, Efthimiou J, Mori J, Kim YI, Thomas E, Wilson L, Harland R, Mathews N, Cockerill S, Powell K, Littler E. A Randomized, Placebo-Controlled, Respiratory Syncytial Virus Human Challenge Study of the Antiviral Efficacy, Safety, and Pharmacokinetics of RV521, an Inhibitor of the RSV-F Protein. Antimicrob Agents Chemother. 2020 Jan 27;64(2):e01884-19. doi: 10.1128/AAC.01884-19. Print 2020 Jan 27.

  PMID: 31712214 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

sisunatovir

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 23, 2017
• Study Start: July 19, 2017
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)