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

Respiratory Syncytial Virus (RSV) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06067191
• Other study ID #: REVD002
• Secondary ID: C5251002
• Status: Completed
• Phase: Phase 1
• Start date: August 8, 2022
• Est. completion date: December 2, 2022

Study information

• Verified date: October 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Most vulnerable populations include babies, the elderly and patients that have received a bone marrow transplant.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus (RSV)
• Virus Diseases

Intervention

Drug:
• RV299
Oral Suspension
• Placebo
matching placebo

Locations

Country	Name	City	State
United Kingdom	Pfizer	London

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) for RSV viral load measured by quantitative real time reverse transcription polymerase chain reaction (qRT-PCR) in nasal washes in participants inoculated with RSV-A Memphis 37b		Day 1 to Day 12
Secondary	Peak viral load of RSV as defined by the maximum viral load determined by qRT-PCR measured in nasal samples		Day 1 to Day 12
Secondary	Time (days) to confirmed negative test by qRT-PCR measurements in nasal samples		Day 1 to Day 12
Secondary	Time (days) to peak qRT-PCR in nasal samples		Day 1 to Day 12
Secondary	Area under the viral load-time curve (VL-AUC) of RSV challenge as determined by viral culture on nasal samples		Day 1 to Day 12
Secondary	Peak viral load of RSV as defined by maximum viral load determined by viral culture measurements in nasal samples		Day 1 to Day 12
Secondary	Time (days) to confirmed negative test by viral culture measurements in nasal samples		Day 1 to Day 12
Secondary	Area under the curve over time of total clinical symptoms (TSS-AUC)	TSS measured from 10 symptoms collected 3 times daily	Day 1 to Day 12
Secondary	TSS-AUC change from baseline (TSS-AUC-CFB)	TSS measured from 10 symptoms collected 3 times daily	Day 1 to Day 12
Secondary	Peak total clinical symptoms (TSS)	TSS measured from 10 symptoms collected 3 times daily	Day 1 to Day 12
Secondary	Individual maximum daily sum of symptom score		Day 1 to Day 12
Secondary	Time (days) to symptom resolution		Day 1 to Day 10
Secondary	Total weight of mucus produced		Day 1 to Day 12
Secondary	Total number of tissues used		Day 1 to Day 12
Secondary	Incidence of AEs		Day 1 to Day 12
Secondary	Incidence of SAEs		Day 1 to Day 12
Secondary	Incidence of AEs related to viral challenge		Day 0 to Day 28
Secondary	Incidence of SAEs related to viral challenge		Day 0 to Day 28
Secondary	Use of concomitant medications from viral challenge		Day 0 to Day 28
Secondary	Time to maximum plasma concentration (tmax)		Day 1 to Day 12
Secondary	Terminal half life (t1/2)		Day 1 to Day 12
Secondary	Area under the plasma concentration-time curve (AUCtau)		Time 0 hours after Dose 1 to 96 hours after Dose 10
Secondary	Area under the plasma concentration-time curve (AUC24)		Time 0 to Time 24 hours
Secondary	Area under the plasma concentration-time curve (AUCinfinity)		Time 0 hours after Dose 1 to 96 hours after Dose 10
Secondary	Maximum concentration (Cmax)		Time 0 hours after Dose 1 to 96 hours after Dose 10

External Links

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