Back to resultsSafety, Pharmacokinetics,and Antiviral Activity of RV299 Against Respiratory Syncytical Virus (RSV)
Primary Purpose
Respiratory Syncytial Virus (RSV)
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
RV299
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Respiratory Syncytial Virus (RSV) focused on measuring Anti-viral, Challenge
Eligibility Criteria
Inclusion Criteria: Total body weight >= 50 kg and body mass index (BMI) >=18 kg/m2 and <=35 kg/m2 in good health with no history, or current evidence of clinically significant medical condition of laboratory, ECG or vital sign abnormality Sero suitable for challenge virus Exclusion Criteria: History of or currently active symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to first study visit Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immunosuppression),metabolic, urological, renal, neurological, or psychiatric disease and/or other major disease females who are breastfeeding or have been pregnant within 6 months prior to the study or have a positive pregnancy test Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction Any significant abnormality altering the anatomy of the nose in a substantial way Any clinically significant history of epistaxis (large nosebleeds) Any nasal or sinus surgery within 3 months of first study visit Evidence of vaccinations within 4 weeks of Day 0 Receipt of blood or blood products, or loss of 550 mL or more blood within last 3 months Receipt of 3 or more investigational drug within last 12 months Prior inoculation with a virus from the same virus-family as the challenge Prior participation in another HVC study with a respiratory virus in last 3 months Use or anticipated use during the conduct of the study of protocol specified concomitant medications Systemic antiviral administration within 4 weeks of viral challenge Confirmed positive test for drugs of abuse History or presence of alcohol addiction, or excessive use of alcohol A forced expiratory volume in 1 second (FEV1) <80% Positive HIV, hepatitis B virus, or hepatitis C virus test Presence of fever upto 2 days prior to Day 0.
Sites / Locations
- Pfizer
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
spray-dried dispersion (SDD) for Oral Suspension
spray-dried dispersion (SDD) for Oral Suspension
Outcomes
Primary Outcome Measures
Area under the curve (AUC) for RSV viral load measured by quantitative real time reverse transcription polymerase chain reaction (qRT-PCR) in nasal washes in participants inoculated with RSV-A Memphis 37b
Secondary Outcome Measures
Peak viral load of RSV as defined by the maximum viral load determined by qRT-PCR measured in nasal samples
Time (days) to confirmed negative test by qRT-PCR measurements in nasal samples
Time (days) to peak qRT-PCR in nasal samples
Area under the viral load-time curve (VL-AUC) of RSV challenge as determined by viral culture on nasal samples
Peak viral load of RSV as defined by maximum viral load determined by viral culture measurements in nasal samples
Time (days) to confirmed negative test by viral culture measurements in nasal samples
Area under the curve over time of total clinical symptoms (TSS-AUC)
TSS measured from 10 symptoms collected 3 times daily
TSS-AUC change from baseline (TSS-AUC-CFB)
TSS measured from 10 symptoms collected 3 times daily
Peak total clinical symptoms (TSS)
TSS measured from 10 symptoms collected 3 times daily
Individual maximum daily sum of symptom score
Time (days) to symptom resolution
Total weight of mucus produced
Total number of tissues used
Incidence of AEs
Incidence of SAEs
Incidence of AEs related to viral challenge
Incidence of SAEs related to viral challenge
Use of concomitant medications from viral challenge
Time to maximum plasma concentration (tmax)
Terminal half life (t1/2)
Area under the plasma concentration-time curve (AUCtau)
Area under the plasma concentration-time curve (AUC24)
Area under the plasma concentration-time curve (AUCinfinity)
Maximum concentration (Cmax)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06067191
Brief Title
Safety, Pharmacokinetics,and Antiviral Activity of RV299 Against Respiratory Syncytical Virus (RSV)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
December 2, 2022 (Actual)
Study Completion Date
December 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus (RSV)
Keywords
Anti-viral, Challenge
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
spray-dried dispersion (SDD) for Oral Suspension
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
spray-dried dispersion (SDD) for Oral Suspension
Intervention Type
Drug
Intervention Name(s)
RV299
Intervention Description
Oral Suspension
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Area under the curve (AUC) for RSV viral load measured by quantitative real time reverse transcription polymerase chain reaction (qRT-PCR) in nasal washes in participants inoculated with RSV-A Memphis 37b
Time Frame
Day 1 to Day 12
Secondary Outcome Measure Information:
Title
Peak viral load of RSV as defined by the maximum viral load determined by qRT-PCR measured in nasal samples
Time Frame
Day 1 to Day 12
Title
Time (days) to confirmed negative test by qRT-PCR measurements in nasal samples
Time Frame
Day 1 to Day 12
Title
Time (days) to peak qRT-PCR in nasal samples
Time Frame
Day 1 to Day 12
Title
Area under the viral load-time curve (VL-AUC) of RSV challenge as determined by viral culture on nasal samples
Time Frame
Day 1 to Day 12
Title
Peak viral load of RSV as defined by maximum viral load determined by viral culture measurements in nasal samples
Time Frame
Day 1 to Day 12
Title
Time (days) to confirmed negative test by viral culture measurements in nasal samples
Time Frame
Day 1 to Day 12
Title
Area under the curve over time of total clinical symptoms (TSS-AUC)
Description
TSS measured from 10 symptoms collected 3 times daily
Time Frame
Day 1 to Day 12
Title
TSS-AUC change from baseline (TSS-AUC-CFB)
Description
TSS measured from 10 symptoms collected 3 times daily
Time Frame
Day 1 to Day 12
Title
Peak total clinical symptoms (TSS)
Description
TSS measured from 10 symptoms collected 3 times daily
Time Frame
Day 1 to Day 12
Title
Individual maximum daily sum of symptom score
Time Frame
Day 1 to Day 12
Title
Time (days) to symptom resolution
Time Frame
Day 1 to Day 10
Title
Total weight of mucus produced
Time Frame
Day 1 to Day 12
Title
Total number of tissues used
Time Frame
Day 1 to Day 12
Title
Incidence of AEs
Time Frame
Day 1 to Day 12
Title
Incidence of SAEs
Time Frame
Day 1 to Day 12
Title
Incidence of AEs related to viral challenge
Time Frame
Day 0 to Day 28
Title
Incidence of SAEs related to viral challenge
Time Frame
Day 0 to Day 28
Title
Use of concomitant medications from viral challenge
Time Frame
Day 0 to Day 28
Title
Time to maximum plasma concentration (tmax)
Time Frame
Day 1 to Day 12
Title
Terminal half life (t1/2)
Time Frame
Day 1 to Day 12
Title
Area under the plasma concentration-time curve (AUCtau)
Time Frame
Time 0 hours after Dose 1 to 96 hours after Dose 10
Title
Area under the plasma concentration-time curve (AUC24)
Time Frame
Time 0 to Time 24 hours
Title
Area under the plasma concentration-time curve (AUCinfinity)
Time Frame
Time 0 hours after Dose 1 to 96 hours after Dose 10
Title
Maximum concentration (Cmax)
Time Frame
Time 0 hours after Dose 1 to 96 hours after Dose 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Total body weight >= 50 kg and body mass index (BMI) >=18 kg/m2 and <=35 kg/m2
in good health with no history, or current evidence of clinically significant medical condition of laboratory, ECG or vital sign abnormality
Sero suitable for challenge virus
Exclusion Criteria:
History of or currently active symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to first study visit
Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immunosuppression),metabolic, urological, renal, neurological, or psychiatric disease and/or other major disease
females who are breastfeeding or have been pregnant within 6 months prior to the study or have a positive pregnancy test
Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction
Any significant abnormality altering the anatomy of the nose in a substantial way
Any clinically significant history of epistaxis (large nosebleeds)
Any nasal or sinus surgery within 3 months of first study visit
Evidence of vaccinations within 4 weeks of Day 0
Receipt of blood or blood products, or loss of 550 mL or more blood within last 3 months
Receipt of 3 or more investigational drug within last 12 months
Prior inoculation with a virus from the same virus-family as the challenge
Prior participation in another HVC study with a respiratory virus in last 3 months
Use or anticipated use during the conduct of the study of protocol specified concomitant medications
Systemic antiviral administration within 4 weeks of viral challenge
Confirmed positive test for drugs of abuse
History or presence of alcohol addiction, or excessive use of alcohol
A forced expiratory volume in 1 second (FEV1) <80%
Positive HIV, hepatitis B virus, or hepatitis C virus test
Presence of fever upto 2 days prior to Day 0.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=REVD002
Description
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Learn more about this trial
Safety, Pharmacokinetics,and Antiviral Activity of RV299 Against Respiratory Syncytical Virus (RSV)
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