A First-In-Human Study to Investigate ATX2417 in Healthy Volunteers

• Research type

  Research Study

• Full title

  A double-blind, randomized, placebo-controlled, dose escalating study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of ATX2417 administered orally and the effect of food on oral absorption in healthy male subjects.

• IRAS ID

  169041

• Contact name

  K M Donaldson

• Sponsor organisation

  Atopix Therapeutics Ltd

• Eudract number

  2014-004999-35

• Duration of Study in the UK

  0 years, 4 months, 17 days

• Research summary

  This first in human study is looking at a drug called ATX2417 which is a drug designed for the treatment of conditions such as such as asthma, atopic dermatitis (eczema) and hay fever.

  The purpose of this study is to look at the safety, tolerability and pharmacokinetics of single and multiple ascending doses of ATX2417 in healthy subjects.

  The population eligible to take part in the study includes healthy male subjects age 18 to 55 years, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests completed during screening at Simbec.

  The study will be conducted in two parts. Part A is single ascending dose (SAD) design, with an additional Fed/Fasted arm. Part B is a multiple ascending dose (MAD) design.

  Approximately 48 healthy male participants (“subjects”) have been enrolled in Part A of the study. A further 16 subjects are planned to be enrolled in Part B.

• REC name

  Wales REC 2

• REC reference

  14/WA/1240

• Date of REC Opinion

  16 Dec 2014

• REC opinion

  Further Information Favourable Opinion