NCT01230645

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 11, 2011

Status Verified

February 1, 2011

Enrollment Period

2 months

First QC Date

October 27, 2010

Last Update Submit

February 10, 2011

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

  • IL8 induction in nasal wash samples

    16 day quarantine period

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

RV568 treatment group

EXPERIMENTAL
Drug: RV568

Placebo treatment group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

RV568DRUG

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

RV568 treatment group
PlaceboDRUG

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

Placebo treatment group

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retroscreen Virology Ltd

London, NW1 0NH, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Anthony Gilbert, MD

    Retroscreen Virology Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 27, 2010

First Posted

October 29, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

February 11, 2011

Record last verified: 2011-02

Locations

GB(1)