Safety, Pharmacokinetics,and Antiviral Activity of RV299 Against Respiratory Syncytical Virus (RSV)

NCT06067191 | Completed Phase 1 Results DMC

• 2 other identifiers: REVD002C5251002
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

Anti-viral; Challenge

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

• Time to Peak qRT-PCR Starting From Initial Administration of IMP

  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

  From initial administration of IMP up to planned discharge from quarantine (up to Day 12)

Study Arms (2)

Active

EXPERIMENTAL

spray-dried dispersion (SDD) for Oral Suspension

Drug: RV299

Placebo

PLACEBO COMPARATOR

spray-dried dispersion (SDD) for Oral Suspension

Drug: Placebo

Interventions

RV299 DRUG

Oral Suspension

Active

Placebo DRUG

matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

London, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: August 8, 2022
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)