AZD2820 SAD study in healthy male volunteers

• Research type

  Research Study

• Full title

  A randomised, single-blind, placebo-controlled single-centre phase I study in healthy male volunteers to assess the safety, tolerability and pharmacokinetics of AZD2820 after single ascending doses

• IRAS ID

  74931

• Contact name

  James Ritter

• Sponsor organisation

  Astra Zeneca

• Eudract number

  2010-024470-19

• Research summary

  The drug being tested in this trial is AZD2820. It is being developed as a possible treatment of obesity. This will be the first time this drug has been given to man. The purpose of this study is to examine the safety and tolerability of single dose levels of AZD2820 in healthy men. The way the body handles (absorbs, distributes, breaks down and excretes) injected doses of AZD2820, is also being investigated. Exploratory objectives are to investigate the effect of the location of administration site, and to collect and store blood samples for future research. After each cohort of subjects any adverse events and the results of safety tests will be reviewed by a safety review committee, and a decision made as to whether to proceed to a higher dose. Subjects will receive one dose level only of either AZD2820 or placebo as subcutaneous (under the skin) injections into the thigh or abdomen. The study will take place at Quintiles Drug Research Unit at Guy's Hospital. Up to 108 healthy male volunteers (age 20-45 years) will participate in the study. Each subject will participate in a screening period, one treatment period lasting for at least 4 days (and 3 nights) and 3 follow up visits. The information gained will help the sponsor of this study to determine whether AZD 2820 is suitable for further studies in humans. The total volume of blood taken will be not greater than 450mL Volunteers taking part in this study will be compensated œ1300

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0022

• Date of REC Opinion

  4 Apr 2011

• REC opinion

  Further Information Favourable Opinion