DB Study of CNTO 3157 in Healthy and Asthmatic Subjects Prot 25May2011

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Intravenous Study in Healthy Subjects and a Multiple-Dose Intravenous Study in Asthmatic Subjects to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of CNTO 3157

• IRAS ID

  76096

• Contact name

  Stephen Evans

• Sponsor organisation

  Janssen-Cilag GmbH

• Eudract number

  2009-017861-51

• Research summary

  The new medicine being tested in this study in both healthy volunteers and asthmatic patients is a compound called CNTO 3157. This compound is being developed for treating asthma and other lung diseases.The purpose of the study is to compare the effects (both good and bad) of CNTO 3157 to those of placebo. In addition, the investigators will measure how much CNTO 3157 is in the blood following a dose of CNTO 3157 and determine if the body makes antibodies to it. An antibody is a protein made by the body in response to a foreign substance.The study has two parts. Part 1 is to assess effects of single ascending administrations of CNTO 3157 in healthy volunteers. Part 2 is to assess the effects of multiple administrations of CNTO 3157 in patients with asthma. In total about 56 healthy volunteers and 16 asthmatic patients will take part.Part 1, done in healthy volunteers, has been completed outside of the UK (but within the EU). Part 2, done in asthmatic patients, has 2 cohorts of 8 patients each and the first cohort has also been completed outside of the UK (but within the EU).This application is for the 2nd cohort of Part 2 in asthmatic patients (10mg/kg). This cohort will be enrolled at the PAREXEL International Early Phase Clinical Unit in the UK (Harrow). The duration of participation of an asthmatic patient will be approximately 24 weeks.Approximately 8 participants, male or female, will be included in this cohort of the study in the UK. Additional subjects may be enrolled if replacements are required.Participants' blood, urine and sputum will be tested, and vital signs measurements and other medical tests will be performed.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0440

• Date of REC Opinion

  22 Jul 2011

• REC opinion

  Further Information Favourable Opinion