- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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:
- Aged 18 to 45 years old and will agree to the use of highly effective methods of contraception.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- hVIVO Services Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RV521
RV521 drug substance in capsule for oral administration
|
RV521 drug in capsules
|
Placebo Comparator: Placebo
Micro-crystalline cellulose in capsule for oral administration
|
Placebo in capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in viral load
Time Frame: Baseline to study day 12
|
Baseline to study day 12
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REVC002
- 2017-001282-24 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Respiratory Syncytial Virus Infections
-
Sanofi Pasteur, a Sanofi CompanyRecruitingRespiratory Syncytial Virus ImmunizationPuerto Rico, United States, Australia, Honduras, Mexico
-
EuBiologics Co.,LtdNot yet recruitingRespiratory Syncytial Virus Infections | Respiratory Syncytial Virus (RSV)
-
Clover Biopharmaceuticals AUS Pty LtdRecruitingRespiratory Syncytial Virus InfectionAustralia
-
Vigonvita Life SciencesRecruitingRespiratory Syncytial Virus InfectionChina
-
AbbVie (prior sponsor, Abbott)CompletedRespiratory Syncytial Virus Infection
-
Sanofi Pasteur, a Sanofi CompanyRecruitingRespiratory Syncytial Virus InfectionUnited States, Puerto Rico
-
PfizerCompletedRespiratory Syncytial Virus InfectionChina
-
Sanofi Pasteur, a Sanofi CompanyCompletedRespiratory Syncytial Virus InfectionHonduras, United States, Chile
-
AbbVie (prior sponsor, Abbott)CompletedRespiratory Syncytial Virus InfectionJapan
-
Shanghai Ark Biopharmaceutical Co., Ltd.Ark Biosciences Pty Ltd.CompletedRESPIRATORY SYNCYTIAL VIRUS INFECTIONSAustralia, Hong Kong, Israel, Lebanon, Malaysia, Poland, Taiwan, Turkey
Clinical Trials on RV521
-
PfizerCompletedRespiratory Syncytial Virus InfectionsUnited States
-
PfizerCompletedRespiratory Syncytial Virus InfectionsUnited Kingdom
-
PfizerCompleted
-
PfizerRecruitingRespiratory Syncytial Virus InfectionsUnited States, Israel, Korea, Republic of, Japan, Canada
-
PfizerTerminatedLower Resp Tract Infection | Respiratory Syncytial Virus (RSV)Spain, Malaysia, Israel, Hungary, Poland, Taiwan, Costa Rica, United Kingdom, Thailand, Argentina, Canada, Chile, Korea, Republic of, New Zealand, Panama
-
PfizerWithdrawnLower Resp Tract Infection | RSV Infection | Stem Cell Transplant Complications
-
PfizerCompletedRespiratory Syncytial Virus InfectionsUnited Kingdom