A Study Of ADC3680B in Healthy Volunteers

• Research type

  Research Study

• Full title

  A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating Study To Assess The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Of Single And Multiple Doses Of ADC3680B Administered Orally to Healthy Volunteers and to Investigate Food Effects on Pharmacokinetics after Single Oral Doses of ADC3680B

• IRAS ID

  38102

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Pulmagen Therapeutics LLP

• Eudract number

  2010-020461-24

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  ADC3680B is a new drug which is being developed for the treatment of both asthma and allergic rhinitis. ADC3680B is thought to work by stopping the action of certain cells in the blood which are involved in inflammation of the lungs in asthmatic people. This could stop the inflammation, wheezing, coughing and difficulty in breathing that is associated with an asthmatic attack. The study will be conducted in a total of 52 healthy volunteers and consists of 3 separate parts (Parts A-C). Part A and B employ a double-blind, randomized, placebo-controlled, dose escalating design to assess the safety, tolerability, pharmacokinetics (how the body handles the drug) and pharmacodynamics (what the drug does to the body) of single and multiple oral doses of ADC3680B. Part C is an open label 2-way crossover study to assess the safety, tolerability and pharmacokinetics of single oral dose of ADC3680B after overnight fast or following a standard high fat meal. The study will assess the safety of the drug as well as the amount of the drug present in the blood (after single and multiple doses) and urine (after single doses in Part A) and any changes to eosinophils (special cells in the blood) caused by the drug.

• REC name

  Wales REC 1

• REC reference

  10/WSE04/28

• Date of REC Opinion

  24 Jun 2010

• REC opinion

  Further Information Favourable Opinion