RV568 - Viral Challenge With RSV

Phase 1

Completed

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Drug: RV568; Drug: Placebo

• Registration Number: NCT01230645
• Lead Sponsor: Respivert Ltd

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-10-29
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-10
• Last Update Posted: 2011-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RV568 treatment group	RV568	-
Placebo treatment group	Placebo	-

Primary Outcome Measures

Name	Time	Method
IL8 induction in nasal wash samples	16 day quarantine period

Secondary Outcome Measures

Name	Time	Method
RSV viral load	16 day quarantine period
Changes in symptoms of RSV infection	16 day quarantine period
Assessment of mucus weight and tissue counts	16 day quarantine period
Viable nasal cell counts in nasal washes	16 day quarantine period
Frequency of RSV infection	16 day quarantine period
Plasma RV568 levels	16 day quarantine period
Assessment of IL6 in nasal wash samples	16 day quarantine period

Trial Locations

Locations (1)

Retroscreen Virology Ltd; 🇬🇧 London, United Kingdom