To study the safety, tolerability, PK & efficacy of inhaled GRC 17536.

• Research type

  Research Study

• Full title

  An integrated Phase I/IIa study to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of inhaled GRC 17536 in healthy adult volunteers and multiple ascending doses in patients with mild asthma; and randomised, double-blind, placebo controlled, cross-over study to evaluate the effects of multiple doses of inhaled GRC 17536 on late phase asthmatic response to allergen challenge in patients with mild asthma.

• IRAS ID

  110883

• Contact name

  Leonard Siew

• Sponsor organisation

  Glenmark Pharmaceuticals Europe Ltd

• Eudract number

  2012-002567-99

• Research summary

  GRC 17536 is a drug that may be useful in the treatment of inflammatory lung conditions such as allergic asthma. Allergic asthma is a condition where there is inflammation of the airways due to inhalation of air-borne allergens (i.e cat dander, house dust mite, and grass pollen). This leads to narrowing of the airways resulting in symptoms of wheeze, chest tightness, shortness of breath and cough. Nerve cells have special proteins which can sense irritant stimuli. When these special proteins are activated the nerve cells release a variety of mediators which promote inflammation. GRC17536 is a chemical which blocks one of these special proteins on nerve cells and therefore has the potential to reduce airways inflammation in asthma. There are 3 parts to this study. The purpose of the first 2 parts of the study is to examine the safety, tolerability, and the way the body handles various increasing single inhaled doses of GRC 17536 in healthy subjects (PART A), and various increasing multiple inhaled doses of GRC 17536 in patients with asthma(PART B). The purpose of the 3rd part of the study (Part C) is to investigate the effect of GRC 17536 on the allergic inflammatory response due to inhaled air-borne allergen in patients with mild asthma. Part A will involve at least 36 healthy male volunteers divided into six groups. Each group will be admitted to the research unit for two nights and three days. This will be followed by seven outpatient visits and an outpatient follow up visit 15 days after dosing with study medication. Part B will involve 24 patients with asthma divided into three groups. Each group will be admitted to the research unit for at least 8 nights and 9 days. This will be followed by an outpatient visit and an outpatient follow up visit 15 days after receiving the first dose of study medication. Part C will involve 24 patients with asthma. There will be two screening outpatient visits, six admissions to the research unit (2 nights and 3 days each), 3 outpatient visits, and a follow-up visit 7 days after receiving the final dose of study medication. The study will start with Part A. Part B will commence after the review of the safety data from Part A. While Part C will commence after the review of the safety data from Part B.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/1276

• Date of REC Opinion

  1 Oct 2012

• REC opinion

  Further Information Favourable Opinion