STUDY OF ADC3322 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 ADC3322 Administered By Oral Inhalation In Healthy Volunteers

• IRAS ID

  16781

• Contact name

  Salvatore Febbraro,MD

• Sponsor organisation

  Argenta Discovery Ltd

• Eudract number

  2009-009504-39

• ISRCTN Number

  1

• Research summary

  ADC3322 is a new inhaled anti-inflammatory drug which is being developed for the treatment of the breathing disease, Chronic Obstructive Pulmonary Disease (COPD). The study will assess the safety of ADC3322 and blood will be taken to determine levels of the drug after single and multiple doses in males and females. The study will also assess the urine levels of the drug after single doses in Part A. The study will be conducted in 3 Parts:Part A will be of approximately 7 weeks in duration and will consist of single doses in healthy male volunteers aged between 18 and 55 years of age. Part B will be of approximately 4 weeks in duration and will consist of single doses in healthy female volunteers aged between 18 and 55 years of age who are of non-childbearing potential.Part C will be of approximately 5 weeks in duration and will consist of multiple doses in healthy male volunteers aged between 18 and 55 years of age.

• REC name

  Wales REC 1

• REC reference

  09/WSE04/15

• Date of REC Opinion

  27 Mar 2009

• REC opinion

  Further Information Favourable Opinion