A Study Of GSK679586A When Infused Into Healthy And Mild Asthmatic Volunteers

This is a two part study. Part I is designed to test single doses of GSK678586A in healthy volunteers. Part II is designed to test repeat doses (two doses) of GSK679586A in patients with mild asthma. Both parts are designed to investigate the safety, tolerability and the way the body absorbs GSK679586A when given by intravenous infusion (through a vein in your arm).

Official Title

A Dose-Escalating Study of the Safety and Pharmacokinetics of GSK679586A in Healthy Volunteers and Mild Asthmatics.

Conditions

• Asthma

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study

Further Details

• Primary Outcomes: Safety and tolerability in healthy volunteers for 56 days from single dosing.; Safety and tolerability in mild asthmatics for 84 days from first of two doses.; Assessed using clinical safety assessments and blood and urine analysis.
• Secondary Outcomes: Blood sampling upto 56 days in Part I and 84 days in Part II, to measure drug levels.; Effects on blood and lung function. Samples taken upto day 56 in Part I, Day 84 in Part II. Lung function at screening, day 41 and in final week of part II.

Study Start

November 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 65 Years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers

Inclusion criteria:

• Part I subjects must be healthy and not be on any medication.
• Part II subjects must have a documented history of mild asthma, first diagnosed at least 6 months before the screening visit and treated only with intermittent short-acting beta agonist inhalation therapy.
• Part II subjects must give a positive skin prick test to a common allergen at the screening visit.
• Males must be 18-65 yrs old and females must be 18-50 yrs old and either be post-menopausal or surgically sterile.
• Subjects must weigh more than 50kg and have a BMI between 19 and 29.9kg/m2.
• Subjects must be non-smokers.

Exclusion criteria:

• The subject has previously been exposed to humanized antibody therapy.
• The subject has a strong family history of cytokine-related diseases such as diabetes type I, multiple sclerosis, Crohn’s disease, rheumatoid arthritis and sarcoidosis.
• The subject has a history of active or latent tuberculosis or has been exposed to someone with active tuberculosis in the previous 6 months.
• The subject intends to travel to a country with a high risk of tuberculosis until the end of the study.
• The subject has a history of chronic urogenital infections and other chronic infections.
• The subject has had a vaccination in the previous 2 months.
• The subject has participated in another clinical trial within 30 days of the first dosing of this study, or longer depending on the drug taken in the previous study.
• The subject has a history of blood donation (450mL) within 2 months of starting the clinical study.
• The subject regularly drinks more than 21 units a week (male) or 14 units a week (female). 1 unit is equivalent to a half-pint of beer (220ml), 1 measure of spirits (25ml) or 1 glass of wine (125ml).
• The subject has tested positive to Hepatitis B or C within 3 months of the screening visit.
• The subject has tested positive to HIV antibodies.
• Subjects in Part I must not have a history of breathing problems.
• Subjects in Part II must not have a history of respiratory tract infections or worsening asthma symptoms within 4 weeks of the screening visit.
• Subjects in Part II must be able to avoid taking anti-histamines for 2 48hour – periods during the study.
• Subjects in Part II must be able to avoid taking astemizole for the duration of the study.
• Subjects in Part II must not be undergoing de-sensitization therapy.
• Subjects in Part II must not have a history of life-threatening asthma.
• Subjects in Part II must not have taken oral or injectable corticosteroids within 8 weeks before the screening visit.
• Subjects in Part II must not have taken inhaled, intranasal or topical steroids in less than 4 weeks before the screening visit or have a current diagnosis of severe hayfever such that intranasal steroids are required less than 4 weeks before the screening visit.
• Subjects in Part II must not have taken drugs called xanthines (not including caffeine), anticholinergics, cromoglycates and/or long acting beta-agonists within 1 week of the screening visit or used leukotriene antagonists within 2 weeks of the screening visit.
  

  Total Enrolment

  56

  Contact Details

  GSK Clinical Trials Call Center, Melbourne, Victoria, 8008, Australia; Recruiting GSK Clinical Trials Call Center 1-877-379-3718

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