A phase 1 study with CDP6038 administered to Japanese male subjects

• Research type

  Research Study

• Full title

  A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE-CENTER, SINGLE DOSE STUDY TO EVALUATE THE SAFETY AND TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO HEALTHY JAPANESE MALES.

• IRAS ID

  63278

• Contact name

  Daryl Bendel

• Sponsor organisation

  UCB Pharma SA

• Eudract number

  2010-022543-38

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a Phase 1, single-dose, double-blind, placebo-controlled, randomized study to look at the safety and tolerability of CDP6038 given by subcutaneous (under skin) injection to healthy Japanese males. CDP6038 is a new investigational drug being developed for the treatment of rheumatoid arthritis. Twenty Japanese make subjects will take part in the study and each subject will be randomized equally to 1 of 5 dose groups: CDP6038 0.3mg/kg, 1mg/kg, 3mg/kg, 6mg/kg, or placebo. The dose is mg/kg body weight. The subjects will be follow up for 16 weeks after the administration of the study drug.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/89

• Date of REC Opinion

  11 Nov 2010

• REC opinion

  Favourable Opinion