MEDI2338 safety in subjects with chronic obstructive pulmonary disease

• Research type

  Research Study

• Full title

  A Phase 1, Single Ascending Dose Study to Evaluate the Safety of MEDI2338 in Subjects with Chronic Obstructive Pulmonary Disease

• IRAS ID

  67327

• Contact name

  John Lambert

• Sponsor organisation

  MedImmune Ltd

• Eudract number

  2010-022879-54

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Chronic obstructive pulmonary disease (COPD) includes persistent bronchitis and emphysema. With COPD, the flow of air into the lungs becomes restricted causing cough and shortness of breath. Often COPD patients have increased symptoms called an exacerbation. Interleukin-1? (IL-18) is a protein made by the body that increases inflammation. Levels of IL-18 in both blood and sputum are increased in people with COPD. MEDI2338 is a monoclonal antibody made in the laboratory and attaches to an IL-18 receptor. When MEDI2338 attaches to the IL-18 receptor, the level of IL-18 is reduced. This may help control the symptoms of people with COPD and reduce exacerbations.The purpose of this study is to evaluate the safety and pharmacokinetics of a MEDI2338 infusion.The first in human study will be performed at the PAREXEL International Early Phase Clinical Units in the UK (Harrow) and South Africa (George, Port Elizabeth and Bloemfontein).Approximately thirty participants will be randomised to receive a single IV dose of MEDI2338 (10, 30, 100, 300, or 1000 mg) or placebo in one of 5 dose cohorts. There will be three participants each in Cohorts 1 and 2; and eight participants each in Cohorts 3-5. Cohorts 1 and 2 participants will receive MEDI2338. Cohorts 3-5 participants will be randomised to receive either MEDI2338 or placebo with a 3 out of 4 chance of getting MEDI2338.Participants blood will be tested and vital signs and medical tests will be performed. The effect of MEDI2338 on lung airflow, heart function, and participants' general wellbeing will be recorded. The pharmacokinetics and antibody production to MEDI2338 will be determined. Biomarkers in participants' blood and mucus will also be determined. An optional DNA test may be done as variations in IL-18 DNA may affect the level of IL-18 protein in blood and to determine response to MEDI2338.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  11/H0405/6

• Date of REC Opinion

  7 Feb 2011

• REC opinion

  Further Information Favourable Opinion