Dose-Ranging, Double Blind, Placebo Controlled Study of Inhaled PUR003

• Research type

  Research Study

• Full title

  A RANDOMIZED, PHASE IB, DOSE-RANGING, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INHALED PUR003 ON A CONTROLLED INFLUENZA VIRUS CHALLENGE IN HEALTHY ADULT SUBJECTS

• IRAS ID

  22938

• Sponsor organisation

  Pulmatrix Inc.

• Eudract number

  2009-012557-38

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The aim of the study is to determine whether or not an inhaled investigational medicinal product (IMP [PUR003]) is effective and safe as a treatment for flunza virus. To see if this works effectively we will ask up to 24 (two groups: 16 IMP and 8 placebo) to take different doses of the drug and compare the effects to those who receive just water (placebo/dummy). These volunteers will be asked, following consent, to have an initial blood sample taken; this sample is then tested to ensure that they do not have natural antibodies to the strain ofluvirus being used.All eligible volunteers will be infected with a milfluvirus (A/Wisconsin/67/2005 [H3N2]) and asked to remain in a comfortable quarantine facility with trained medical staff. They are not allowed to mix with other members of the public until the study is complete. This study is for a period of ten days, with possibly one extra day's stay (if still showing any symptoms of flunza on planned discharge day.Salty water will be gently washed into the nose each day and a sample collected to determine if the virus is present. Small amounts of blood, c. two teaspoonfuls will be taken on a few occasions during the study to determine whether or not people have made antibodies to the virus.The volunteers will have a physical exam performed daily by a doctor and they will complete a diary card twice a day describing how they feel. They will also take their temperature four times a day. Finally the subject will be asked to collect their tissues over a 24 hour period and these will then be weighed.There are strict rules regarding who can volunteer for this study to ensure those in whom flunza virus can cause complications are not included.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/73

• Date of REC Opinion

  29 Jun 2009

• REC opinion

  Further Information Favourable Opinion