Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RV299 · 2 trials · 2 indications
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.
Listings and summary tables of AEs will be based on TEAEs (defined as events starting, or worsening, after the first dose of RV299).
Blood and urine tests will be conducted at a central laboratory. Results at each visit will be summarized using the statistics n, mean, standard deviation, median, minimum and maximum.
Parameters collected will be: PR interval (msec); QRS interval (msec); QT interval (msec); QTcB interval (msec); QTcF interval (msec); Heart rate (bpm). Results at each visit will be summarized using the statistics n, mean, standard deviation, median, minimum and maximum.
Tympanic temperature will be collected in degrees Celsius (°C). Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.
Blood pressure (systolic and diastolic) will be measure in mm Hg. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.
Heart rate will be measure in beats per minute (bpm). Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.
Respiratory rate will be measured in breaths per minute. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.
Pharmacokinetic analysis will include listings and summaries of midazolam concentration by time point and analysis of relationship with dose and body weight.
Pharmacokinetic analysis will include listings and summaries of midazolam concentration by time point and analysis of relationship with dose and body weight
Pharmacokinetic analysis will include listings and summaries of midazolam concentration by time point and analysis of relationship with dose and body weight
Pharmacokinetic analysis will include listings and summaries of midazolam concentration by time point and analysis of relationship with dose and body weight
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | spray-dried dispersion (SDD) for Oral Suspension |
| Placebo | PLACEBO_COMPARATOR | spray-dried dispersion (SDD) for Oral Suspension |
| Part A Single Ascending Dose (SAD) - RV299/Placebo | EXPERIMENTAL | Participants will receive RV299 or placebo as a single dose on Day 1. Sentinel dosing will be used (one on RV299 and one on placebo) before the rest of the cohort are dosed together. |
| Part B Multiple Ascending Dose (MAD) - RV299/Placebo | EXPERIMENTAL | Participants will receive RV299 or placebo twice daily on Day 1-4 and a single dose on Day 5. Participants in each cohort will receive ascending doses of RV299, depending on emerging safety and PK data. Part B, Cohort 3 will investigate interaction between midazolam and RV299. Participants will receive a single dose of midazolam on Day 1 and Day 7, and receive RV299 twice daily on Days 2 - 6 |
| Part C Food Effect (FE)- RV299 | EXPERIMENTAL | Participants will receive RV299 as a single dose on Day 1 and Day 5; treatment will be administered in the first treatment period fasted and the second treatment period fed (or vice versa). |
| Name | Type | Description |
|---|---|---|
| RV299 | DRUG | Oral Suspension |
| Placebo | DRUG | matching placebo |
| Midazolam | DRUG | pre-filled oral syringe |
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...
RV299 is an investigational small molecule being developed by Pfizer for the treatment and prevention of Respiratory Syncytial Virus (RSV) infections. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
RV299 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical trials for Respiratory Syncytial Virus (RSV) infections.
RV299 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one evaluating safety, tolerability, and pharmacokinetics in healthy adults, and another assessing safety and antiviral activity against RSV. The drug remains investigational and is not yet approved.
RV299 has been studied in two completed Phase 1 trials: NCT06033612, a safety, tolerability, pharmacokinetics, and food effect study in healthy adults, and NCT06067191, a safety, pharmacokinetics, and antiviral activity study against RSV. Both trials were conducted in the United Kingdom.
No alternative names for RV299 have been disclosed. The drug is identified solely by its code name RV299 in clinical trial registrations and is being developed by Pfizer for Respiratory Syncytial Virus infections.