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RV299

Phase 1

Respiratory Syncytial Virus (RSV) | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Oct 21, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment82
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06067191Safety, Pharmacokinetics,and Antiviral Activity of RV299 Against Respiratory Syncytical Virus (RSV)PHASE1 COMPLETED 82 — — Aug 8, 2022Dec 2, 2022Oct 21, 20241 United Kingdom
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Study Endpoints
Primary Endpoints
Area Under the Curve (AUC) for RSV-A Memphis 37b Viral Load Determined by Quantitative Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR)
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.

Secondary Endpoints
Peak Viral Load of RSV Determined by qRT-PCR
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
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
From peak qRT-PCR measurement to the first confirmed negative qRT-PCR test or censoring date (up to Day 12)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
ActiveEXPERIMENTALspray-dried dispersion (SDD) for Oral Suspension
PlaceboPLACEBO_COMPARATORspray-dried dispersion (SDD) for Oral Suspension
Interventions
NameTypeDescription
RV299DRUGOral Suspension
PlaceboDRUGmatching placebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 Crite...

Countries:United Kingdom
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