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

• Status: Completed
• Trial end date: 2022-12-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer

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.