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

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.