Title

RV568 - Viral Challenge With RSV
A Randomized, Single-blind, Placebo-controlled, Parallel Group Study to Investigate the Effects of Intranasal RV568 (400μg) Administered Twice Daily to Adult Male Volunteers Experimentally Inoculated With Live Respiratory Syncytial Virus
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    rv568 ...
  • Study Participants

    42
RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 is effective in reducing the inflammation caused by viral infections such as RSV (respiratory syncytial virus).
Study Started
Oct 31
2010
Primary Completion
Dec 31
2010
Study Completion
Jan 31
2011
Last Update
Feb 11
2011
Estimate

Drug RV568

RV568 400 ug administered as nasal drops twice daily for 10 days (Day -1 to Day 8)

Drug Placebo

Placebo administered as nasal drops twice daily for 10 days (Day -1 to Day 8)

RV568 treatment group Experimental

Placebo treatment group Placebo Comparator

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:

less than 3 years of age;
any person with any known immunodeficiency;
any person receiving immunosuppressant medications;
any person undergoing or soon to undergo cancer chemotherapy within 28 days of viral challenge;
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
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
No Results Posted