Phase 1
N=79
Safety, Pharmacokinetics,and Antiviral Activity of RV299 Against Respiratory Syncytical Virus (RSV)
Respiratory Syncytial Virus (RSV)
Bottom Line
View on ClinicalTrials.gov: NCT06067191 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Area Under the Curve (AUC) for RSV-A Memphis 37b Viral Load Determined by Quantitative Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR) — 350.99; 616.97 Hours*log10 copies per milliliter — p=0.0009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RV299 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) for RSV-A Memphis 37b Viral Load Determined by Quantitative Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR) |
350.99; 616.97 | 0.0009 sig |
| SECONDARY Peak Viral Load of RSV Determined by qRT-PCR |
5.01; 6.23 | 0.0047 sig |
| SECONDARY 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 |
4.2; 8.5 | <0.0001 sig |
| SECONDARY 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 |
2.5; 5.0 | 0.0051 sig |
| SECONDARY Time to Peak qRT-PCR Starting From Initial Administration of IMP |
1.5; 1.5 | 0.0077 sig |
| SECONDARY Area Under the Viral Load-Time Curve (VL-AUC) for RSV-A Memphis 37b Determined by Viral Culture |
106.48; 212.51 | 0.0268 sig |
| SECONDARY Peak Viral Load of RSV Determined by Viral Culture |
2.43; 3.63 | 0.0865 |
| SECONDARY Time to Confirmed Negative Test by Viral Culture Measurement Starting From at Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure |
3.2; 5.0 | 0.0008 sig |
| SECONDARY 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 |
1.3; 1.6 | 0.8579 |
| SECONDARY Area Under the Curve Over Time of Total Clinical Symptoms as Measured From 10 Symptoms Within the Graded Symptom Scoring System |
180.77; 240.94 | 0.0658 |
| SECONDARY 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 |
-17.23; 103.75 | 0.0658 |
| SECONDARY Overall Peak Total Clinical Symptoms (TSS) Score |
3.30; 3.90 | 0.2030 |
| SECONDARY Individual Maximum Daily Peak Symptom Score |
2.1; 1.2; 2.0; 1.8; 1.9; 3.0 | — |
| SECONDARY Time to Symptom Resolution Starting at Initial Administration of IMP to 24 Hours Symptom Free |
3.99; 6.40 | — |
| SECONDARY Time to Symptom Resolution Starting at Peak Symptoms After Initial Administration to 24 Hours Symptom Free |
1.44; 3.67 | — |
| SECONDARY Time to Peak Symptom Score From Initial Administration of IMP |
1.61; 2.74 | — |
| SECONDARY Total Weight of Mucus Produced Starting at Initial Administration of IMP up to Planned Discharge From Quarantine |
7.49; 16.23 | — |
| SECONDARY Total Number of Tissues Used by Participants Starting At Initial Administration of IMP up to Planned Discharge From Quarantine |
14.09; 28.17 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
12; 12; 0; 0 | — |
| SECONDARY Number of Participants With AEs Related to Viral Challenge |
2; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Concomitant Medications |
17; 16 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) for RV299 |
2.85; 2.45 | — |
| SECONDARY Terminal Half-Life (t1/2) for RV299 |
NA; 12.1 | — |
| SECONDARY Maximum Observed Plasma Concentration for RV299 |
448; 1144 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to the End of the Dosing Interval for RV299 |
3500; 7845 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve Over the Last 24 Hours Dosing Interval for RV299 |
NA | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity for RV299 on Day 1 |
NA | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT06067191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.