Respiratory Syncytial Virus (RSV)Phase 1NCT06067191
Safety, Pharmacokinetics,and Antiviral Activity of RV299 Against Respiratory Syncytical Virus (RSV)
A Phase 1 study testing RV299 in people with Respiratory Syncytial Virus (RSV), run by Pfizer at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- RV299
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Aug 2022to 2 Dec 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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)
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- RV299, Placebo
- Keywords
- Anti-viral, Challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV299Drug
Oral Suspension
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | spray-dried dispersion (SDD) for Oral Suspension Receives: Drug: RV299 |
| Placebo | Placebo comparator | spray-dried dispersion (SDD) for Oral Suspension Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) for RSV-A Memphis 37b Viral Load Determined by Quantitative Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR)
Area under the curve (AUC) for RSV viral load measured in nasal washes by qRT-PCR in participants inoculated with RSV-A Memphis 37b, from initial administration of IMP up to the morning of Day 12 (Quarantine discharge) was presented in this outcome measure.
Measured: From initial administration of IMP up to the morning of quarantine discharge (up to Day 12)
Secondary outcomes (26)
Peak Viral Load of RSV Determined by qRT-PCR
Peak viral load of RSV as defined by the maximum viral load determined by qRT-PCR measurements in nasal samples starting from initial administration of IMP up to planned discharge from quarantine was reported in this outcome measure.
Measured: From initial administration of IMP up to planned discharge from quarantine (Up to Day 12)
Time to Confirmed Negative Test by qRT-PCR Measurement Starting From Initial Administration of Investigational Medicinal Product (IMP) to First Confirmed Undetectable Assessment After Peak Measure
The time from the first administration of IMP to the first confirmed negative qRT-PCR test after the peak qRT-PCR measurement was calculated as: Date and time of first confirmed negative test after peak qRT-PCR measurement minus Date and time of first IMP administration. A negative test was defined as two consecutive 'Not Detected' results in the qRT-PCR test. The peak qRT-PCR was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants without a confirmed undetectable assessment after their peak, were censored at their last detected qRT-PCR assessment.
Measured: From first administration of IMP to the first confirmed negative qRT-PCR test or censoring date (up to Day 12)
Time to Confirmed Negative Test by qRT-PCR Measurement Starting From Peak qRT-PCR After Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure
The time from the peak qRT-PCR measurement after administration of IMP to the first confirmed negative qRT-PCR test was calculated as (Date and time of first confirmed negative test after peak qRT-PCR measurement minus Date and time of peak qRT-PCR measurement). A negative test was defined as two consecutive 'Not Detected' results in the qRT-PCR test. The peak qRT-PCR was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants without a confirmed undetectable assessment after their peak, were censored at their last detected qRT-PCR assessment.
Measured: From peak qRT-PCR measurement to the first confirmed negative qRT-PCR test or censoring date (up to Day 12)
Time to Peak qRT-PCR Starting From Initial Administration of IMP
The time to the peak qRT-PCR measurement starting from the initial administration of IMP was calculated as: Date and time of peak qRT-PCR measurement minus Date and time of first IMP administration. The peak qRT-PCR was defined as the highest viral load value obtained by a participant after their first administration of IMP.
Measured: From first administration of IMP to peak qRT-PCR measurement (up to Day 12)
Area Under the Viral Load-Time Curve (VL-AUC) for RSV-A Memphis 37b Determined by Viral Culture
Area under the viral load-time curve (VL-AUC) of RSV challenge virus as determined by viral culture on nasal samples, starting at initial administration of IMP up to planned discharge from quarantine was reported in this outcome measure.
Measured: From initial administration of IMP up to planned discharge from quarantine (up to Day 12)
Peak Viral Load of RSV Determined by Viral Culture
Peak viral load of RSV as defined by the maximum viral load determined by viral culture measurements in nasal samples starting from initial administration of IMP up to planned discharge from quarantine was reported in this outcome measure.
Measured: From initial administration of IMP up to planned discharge from quarantine (up to Day 12)
Time to Confirmed Negative Test by Viral Culture Measurement Starting From at Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure
Time to confirmed negative test by viral culture measurements in nasal samples from initial administration of IMP up to first confirmed negative viral culture measurement after the peak viral culture measurement was calculated as: Date and time of first confirmed negative test after peak viral culture measurement minus Date and time of first IMP administration. A negative test was defined as two consecutive 'Not Detected' results in the viral culture test. The peak viral culture measurement was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants who did not have a confirmed undetectable assessment after their peak viral culture measurement after first administration of IMP were censored at their last detectable assessment.
Measured: From initial administration of IMP up to first confirmed undetectable assessment or censoring date (up to Day 12)
Time to Confirmed Negative Test by Viral Culture Measurement Starting From Peak Viral Culture After Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure
The time from the peak viral culture measurement after administration of IMP to the first confirmed negative viral culture measurement was calculated in days as: Date of and time first confirmed negative test minus Date and time of peak qRT-PCR measurement. A negative test was defined as two consecutive 'Not Detected' results in the viral culture test. The peak viral culture measurement was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants who did not have a confirmed undetectable assessment after their peak viral culture measurement after first administration of IMP were censored at their last detectable assessment.
Measured: From peak qRT-PCR measurement to first confirmed undetectable assessment or censoring date (up to Day 12)
Area Under the Curve Over Time of Total Clinical Symptoms as Measured From 10 Symptoms Within the Graded Symptom Scoring System
Area under the Curve over Time of Total Clinical Symptoms (TSS-AUC) as measured from 10 symptoms within Graded Symptom Scoring System Collected 3 Times Daily Starting at Initial Administration up to Planned Discharge from Quarantine. TSS (from 10 items of the 13-item symptom diary card) was used to calculate the AUC, from the assessment nearest to the time of the first administration of IMP until Day 12. Following types of symptoms were recorded on symptom diary cards: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), higher scores = greater severity of symptoms. Total symptom score was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms.
Measured: From initial administration of IMP (before or after administration) up to planned discharge from quarantine (up to Day 12)
Area Under the Curve Over Time of Total Clinical Symptoms Change From Baseline (TSS-AUC-CFB) as Measured From 10 Symptoms Within the Graded Symptom Scoring System
Area under the curve over time of total clinical symptoms change from baseline (TSS-AUC-CFB) as measured from 10 symptoms within the graded symptom scoring system collected 3 times daily starting at initial administration of IMP up to planned discharge from quarantine (Day 12, am). The following types of symptoms were recorded: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), where higher scores indicated greater severity of symptoms. TSS was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. The AUC calculation was based on the available non-missing calculated total symptom scores between the start and end of the defined AUC time.
Measured: Baseline (assessment nearest to the time of the first administration of IMP) up to Day 12
Overall Peak Total Clinical Symptoms (TSS) Score
Peak total clinical symptoms (TSS) as measured from 10 symptoms within the graded symptom scoring system collected 3 times daily starting from initial administration of IMP up to planned discharge from quarantine. The following types of symptoms were recorded: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), where higher scores indicated greater severity of symptoms. The total symptom score was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. The overall peak score was defined as the highest scoring symptom diary card observed from the first administration of IMP until quarantine discharge.
Measured: From initial administration of IMP (before or after administration) up to planned discharge from quarantine (up to Day 12)
Individual Maximum Daily Peak Symptom Score
Individual maximum daily sum of symptom score from initial administration of IMP up to planned discharge from quarantine. The following types of symptoms were recorded: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), where higher scores indicated greater severity of symptoms. The total symptom score was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. The highest total symptom score recorded on each day, across the three assessments was reported in this outcome measure. The peak daily score was defined as the highest scoring symptom diary card observed on each day from the first administration of IMP until quarantine discharge.
Measured: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9 (days relative to first administration of IMP)
Time to Symptom Resolution Starting at Initial Administration of IMP to 24 Hours Symptom Free
Symptom resolution was defined as a participant scoring 0 for the total symptom score for a 24-hour period (e.g., a minimum of three consecutive symptom diary cards, each with a score of 0) after their peak symptom score. The time from the assessment at the time of the first administration of IMP until symptom resolution was calculated as: Date and time of symptom resolution minus Date and time of assessment at IMP administration. If the peak symptom score occurred on more than one day then the first occurrence was selected. Participants who did not record 24 hours symptom free after their highest total symptom score during the quarantine period were censored at their last assessment.
Measured: From first administration of IMP until time of symptom resolution or censoring date (up to Day 12)
Time to Symptom Resolution Starting at Peak Symptoms After Initial Administration to 24 Hours Symptom Free
Symptom resolution was defined as a participant scoring 0 for the total symptom score for a 24-hour period (e.g., a minimum of three consecutive symptom diary cards, each with a score of 0) after their peak symptom score. The time from the highest total symptom score following administration of IMP until symptom resolution was calculated as: Date and time of symptom resolution minus Date and time of highest total symptom score. If the peak symptom score occurred on more than one day then the first occurrence was selected. Participants who did not record 24 hours symptom free after their highest total symptom score during the quarantine period were censored at their last assessment.
Measured: From time of highest total symptom score until time of symptom resolution or censoring date (up to Day 12)
Time to Peak Symptom Score From Initial Administration of IMP
Time to peak as measured from 10 symptoms within the graded daily symptom scoring system starting from initial administration of IMP to the time of peak daily symptom score. If the peak symptom score occurred on more than one day then the first occurrence was selected. Participants were censored at their last assessment if they did not record any symptoms during the quarantine period.
Measured: From first dose of IMP until time of highest total symptom score or censoring date (Up to Day 12)
Total Weight of Mucus Produced Starting at Initial Administration of IMP up to Planned Discharge From Quarantine
Total weight of nasal mucus was calculated as the sum of mucus weights taken from the assessment at the time of the first administration of IMP (prior to or after dosing, depending on whether dosed in the morning or evening) to morning of Day 12 (Quarantine discharge).
Measured: From first administration of IMP up to planned discharge from quarantine (up to Day 12)
Total Number of Tissues Used by Participants Starting At Initial Administration of IMP up to Planned Discharge From Quarantine
Total number of tissues was counted from the assessment at the time of the first dose of IMP (prior to or after dosing, depending on whether dosed in the morning or evening) to morning of Day 12 (Quarantine discharge).
Measured: From first administration of IMP up to planned discharge from quarantine (up to Day 12)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An adverse event was defined as any untoward medical occurrence in clinical study participants administered a pharmaceutical product. An AE did not necessarily have a causal relationship with the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or important medical event.
Measured: From first dose of IMP until end of follow-up visit (up to Day 28)
Number of Participants With AEs Related to Viral Challenge
An Adverse Event was defined as any untoward medical occurrence in clinical study participants administered a pharmaceutical product. An AE did not necessarily have a causal relationship with the study intervention. Number of participants with AEs possibly, probably or definitely related to viral challenge agents were reported by preferred terms in this outcome measure.
Measured: From viral challenge on Day 0 up to end of follow-up (Day 28)
Number of Participants With Concomitant Medications
Number of participants with concomitant medications were reported in this outcome measure.
Measured: From viral challenge on Day 0 up to end of follow-up (Day 28)
Time to Maximum Plasma Concentration (Tmax) for RV299
Measured: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96-hours post-dose 1 and dose 10
Terminal Half-Life (t1/2) for RV299
Measured: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 and dose 10
Maximum Observed Plasma Concentration for RV299
Measured: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 and dose 10
Area Under the Plasma Concentration-Time Curve From Time Zero to the End of the Dosing Interval for RV299
Area under the plasma concentration-time curve from time zero to the end of the dosing interval for RV299 where dosing interval=12 hours.
Measured: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12 hours post-dose 1 and dose 10
Area Under the Plasma Concentration-Time Curve Over the Last 24 Hours Dosing Interval for RV299
Measured: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24 hours post-dose 1 and dose 10
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity for RV299 on Day 1
Measured: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start8 Aug 2022
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067191
- Sponsor's protocol ID
- REVD002
- Other IDs
- C5251002
- Status last verified
- Jul 2024
- First submitted
- 27 Sep 2023
- Last updated
- 21 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06067191
- Acronym / sponsor ID
- REVD002
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- Anti-viral, Challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Posted 21 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: RV299spray-dried dispersion (SDD) for Oral Suspension |
| Placebo | Placebo comparator | Drug: Placebospray-dried dispersion (SDD) for Oral Suspension |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RV299Oral Suspension | Drug | Active |
| Placebomatching placebo | Drug | Placebo |
Primary outcome
Area Under the Curve (AUC) for RSV-A Memphis 37b Viral Load Determined by Quantitative Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR)
Time frame: From initial administration of IMP up to the morning of quarantine discharge (up to Day 12)
Area under the curve (AUC) for RSV viral load measured in nasal washes by qRT-PCR in participants inoculated with RSV-A Memphis 37b, from initial administration of IMP up to the morning of Day 12 (Quarantine discharge) was presented in this outcome measure.
26 secondary outcomes
Peak Viral Load of RSV Determined by qRT-PCR
Time frame: From initial administration of IMP up to planned discharge from quarantine (Up to Day 12)
Time to Confirmed Negative Test by qRT-PCR Measurement Starting From Initial Administration of Investigational Medicinal Product (IMP) to First Confirmed Undetectable Assessment After Peak Measure
Time frame: From first administration of IMP to the first confirmed negative qRT-PCR test or censoring date (up to Day 12)
Time to Confirmed Negative Test by qRT-PCR Measurement Starting From Peak qRT-PCR After Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure
Time frame: From peak qRT-PCR measurement to the first confirmed negative qRT-PCR test or censoring date (up to Day 12)
Time to Peak qRT-PCR Starting From Initial Administration of IMP
Time frame: From first administration of IMP to peak qRT-PCR measurement (up to Day 12)
Area Under the Viral Load-Time Curve (VL-AUC) for RSV-A Memphis 37b Determined by Viral Culture
Time frame: From initial administration of IMP up to planned discharge from quarantine (up to Day 12)
Peak Viral Load of RSV Determined by Viral Culture
Time frame: From initial administration of IMP up to planned discharge from quarantine (up to Day 12)
Time to Confirmed Negative Test by Viral Culture Measurement Starting From at Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure
Time frame: From initial administration of IMP up to first confirmed undetectable assessment or censoring date (up to Day 12)
Time to Confirmed Negative Test by Viral Culture Measurement Starting From Peak Viral Culture After Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure
Time frame: From peak qRT-PCR measurement to first confirmed undetectable assessment or censoring date (up to Day 12)
Area Under the Curve Over Time of Total Clinical Symptoms as Measured From 10 Symptoms Within the Graded Symptom Scoring System
Time frame: From initial administration of IMP (before or after administration) up to planned discharge from quarantine (up to Day 12)
Area Under the Curve Over Time of Total Clinical Symptoms Change From Baseline (TSS-AUC-CFB) as Measured From 10 Symptoms Within the Graded Symptom Scoring System
Time frame: Baseline (assessment nearest to the time of the first administration of IMP) up to Day 12
Overall Peak Total Clinical Symptoms (TSS) Score
Time frame: From initial administration of IMP (before or after administration) up to planned discharge from quarantine (up to Day 12)
Individual Maximum Daily Peak Symptom Score
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9 (days relative to first administration of IMP)
Time to Symptom Resolution Starting at Initial Administration of IMP to 24 Hours Symptom Free
Time frame: From first administration of IMP until time of symptom resolution or censoring date (up to Day 12)
Time to Symptom Resolution Starting at Peak Symptoms After Initial Administration to 24 Hours Symptom Free
Time frame: From time of highest total symptom score until time of symptom resolution or censoring date (up to Day 12)
Time to Peak Symptom Score From Initial Administration of IMP
Time frame: From first dose of IMP until time of highest total symptom score or censoring date (Up to Day 12)
Total Weight of Mucus Produced Starting at Initial Administration of IMP up to Planned Discharge From Quarantine
Time frame: From first administration of IMP up to planned discharge from quarantine (up to Day 12)
Total Number of Tissues Used by Participants Starting At Initial Administration of IMP up to Planned Discharge From Quarantine
Time frame: From first administration of IMP up to planned discharge from quarantine (up to Day 12)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of IMP until end of follow-up visit (up to Day 28)
Number of Participants With AEs Related to Viral Challenge
Time frame: From viral challenge on Day 0 up to end of follow-up (Day 28)
Number of Participants With Concomitant Medications
Time frame: From viral challenge on Day 0 up to end of follow-up (Day 28)
Time to Maximum Plasma Concentration (Tmax) for RV299
Time frame: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96-hours post-dose 1 and dose 10
Terminal Half-Life (t1/2) for RV299
Time frame: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 and dose 10
Maximum Observed Plasma Concentration for RV299
Time frame: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 and dose 10
Area Under the Plasma Concentration-Time Curve From Time Zero to the End of the Dosing Interval for RV299
Time frame: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12 hours post-dose 1 and dose 10
Area Under the Plasma Concentration-Time Curve Over the Last 24 Hours Dosing Interval for RV299
Time frame: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24 hours post-dose 1 and dose 10
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity for RV299 on Day 1
Time frame: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RV299 in people with Respiratory Syncytial Virus (RSV), run by Pfizer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) for RSV-A Memphis 37b Viral Load Determined by Quantitative Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR) (time frame: From initial administration of IMP up to the morning of quarantine discharge (up to Day 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.