A study to assess the safety, tolerability, PK and POC of Sun S0597
Research type
Research Study
Full title
A Three-Part, Randomised, Double-Blind (S0597 and placebo), Placebo and Active-Controlled, Parallel Group and Cross Over, Single and Multiple Dose Escalating Study to assess the Safety, Tolerability, Pharmacokinetics and a Proof of Concept Allergen Challenge Study assessing the Pharmacodynamics of compound S0597 by Oral Inhalation Route in Healthy Volunteers and Patients with Mild Asthma
IRAS ID
137721
Contact name
Tim Mant
Contact email
Sponsor organisation
Sun Pharma Advanced Clinical Research Ltd
Eudract number
2013-003072-12
Clinicaltrials.gov Identifier
Research summary
Sun S0597 is an investigational medicinal product 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.\n\nThere 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 Sun S0597 in healthy subjects (PART 1), and various increasing multiple inhaled doses of Sun S0597 in patients with asthma(PART 2). The purpose of the 3rd part of the study (Part 3) is to investigate the effect of Sun S0597 on the allergic inflammatory response due to inhaled air-borne allergen in patients with mild asthma.\n\nPart 1 will involve up-to 40 healthy male volunteers divided into five groups. Each group will be admitted to the research unit for three nights and four days. This will be followed by a follow up appointment 7 days after dosing.\n\nPart 2 will involve 24 patients with asthma divided into three groups. Each group will be admitted to the research unit for at least 10 nights and 11 days. This will be followed by an outpatient visit the day after discharge and an outpatient follow up visit 8 days after receiving the first dose of study medication.\n\nPart 3 will involve 18 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\n\nThe study will start with Part 1. Part 2 will commence after the review of the safety data from Part 1. while Part 3 will commence after the review of the safety data from Part 2.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0307
Date of REC Opinion
21 Oct 2013
REC opinion
Further Information Favourable Opinion