Clinical trial NCT01230645 (phase 1, status: completed)
Conditions: respiratory syncytial virus infections
ICD codes: R09.2, A15.7, A15.8, A15.9, J98.9, R06.03, J12.1
Drugs: rv568, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  healthy male subjects aged 18 - 45 years

          -  agreeable to use adequate contraception throughout the study

          -  negative hepatitis B, hepatitis C and HIV screen

          -  negative drugs of abuse, alcohol and nicotine screen

          -  able to provide written informed consent and be willing to comply with the study
             restrictions and requirements

          -  low titres of RSV neutralising antibody measured during screening

        Exclusion Criteria:

          -  acute or chronic illness or clinically relevant abnormality noted at the screening
             visit

          -  presence of febrile illness or symptoms of upper or lower respiratory tract infection
             in the 28 days prior to viral inoculation

          -  history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any
             chronic lung condition

          -  diabetes

          -  history or evidence of autoimmune disease or known impaired immune responsiveness

          -  recent (within the last 3 years) and/or recurrent history of autonomic dysfunction

          -  anatomic or neurological abnormality impairing the gag reflex or associated with an
             increased risk of aspiration, any abnormality significantly altering the anatomy of
             the nose or nasopharynx. Known IgA deficiency, immotile cilia syndrome, or
             Kartagener's syndrome. Any nasal or sinus surgery within 4 months prior to virus
             administration.

          -  history of smoking in the past 6 months

          -  positive test for drugs or alcohol at screening

          -  inadequate venous access

          -  abnormal pulmonary function at screening

          -  abnormal laboratory or ECG at screening

          -  acute or chronic use of medication to treat nasal congestion

          -  use of any prescription drugs, herbal supplements, within 4 weeks prior to virus
             challenge, and/or over-the-counter medication, dietary supplements within 2 weeks
             prior to virus challenge

          -  treatment with systemic glucocorticoids, antiviral drugs, immunoglobulins or blood
             transfusions within 1 month, or any other cytotoxic or immunosuppressive drug within 6
             months prior to dosing. Receipt of any systemic chemotherapy agent at any time

          -  treatment with any investigational drug within 3 months, or prior participation in a
             clinical trial of any RSV IMP, medication or experimental RSV viral challenge
             delivered directly to the respiratory tract within 1 year prior to dosing, or receipt
             of more than 4 investigational drug within 12 months

          -  history of multiple and recurring allergies and/or adverse reaction to any components
             of the challenge virus preparation

          -  allergy to gentamicin

          -  significant history of seasonal hay fever or seasonal allergic rhinitis (SAR),
             perennial allergic rhinitis (PAR), or chronic nasal or sinus condition

          -  intention to travel between first and last visit (to countries for which vaccinations
             are recommended or where high risk of infection exists)

          -  healthcare workers (including doctors, nurses, medical students and allied healthcare
             professionals) anticipated to have patient contact within two weeks of viral challenge

          -  household member or close contact (for an additional 2 weeks after discharge from the
             isolation facility) who is:

               1. less than 3 years of age;

               2. any person with any known immunodeficiency;

               3. any person receiving immunosuppressant medications;

               4. any person undergoing or soon to undergo cancer chemotherapy within 28 days of
                  viral challenge;

               5. any person who has diagnosed emphysema or COPD, is elderly residing in a nursing
                  home, or with severe lung disease or medical condition including but not
                  exclusive to the conditions listed below; or

               6. any person who has received a transplant (bone marrow or solid organ)

          -  employees or relatives of Retroscreen Virology or RespiVert Ltd

          -  other finding in the medical interview, physical exam, or screening investigations
             that, in the opinion of the Investigator, deem the subject unsuitable for the study

          -  subjects who in the opinion of their general practitioner or the Investigator, should
             not participate in the study