A Study to Assess the Safety and Tolerability of Multiple Doses of Multi-Level of a Drug in Subjects With Moderate Asthma

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 30
• Participant gender: Both

Summary

This study includes subjects with asthma to participate in one of three groups and randomly assigned to a group to receive the drug for the study (CAT-354) or placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC
• Last Updated: 2009-09-09

Criteria

Inclusion Criteria:

• Males or infertile females

• Subjects with asthma, well controlled on inhaled corticosteroid and PRN short acting B2 agonist therapy only

• Unchanged dose of inhaled corticosteroid for three months prior to day 0 and no expected need for change in dose during study

• FEV1 greater than or equal to 80% predicted at screening (baseline)

• 18-60 years

• GP diagnosis of asthma of 1 year's min. duration (with respect to Day 0)

• No significant abnormality on clinical examination or medical history (excluding atopic skin signs, symptoms and history)

• 12-lead electrocardiogram with no clinical significant abnormality

• Clinical chemistry hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator

• A negative screen for drugs of abuse and alcohol

• Body weight between 50-120kg

• Subjects aged between 18-40 years inclusive must have BMI 18-32kg/m2 inclusive. Subjects aged between 41-60 years must have BMI between 18-30 kg/m2, inclusive.

Exclusion Criteria:

• Active concomitant disease, with exception of eczema

• Expected onset of seasonal allergy before the administration of the last dose of study medication

• History of severe exacerbation within 3 years of Day 0

• Recorded use of inhaled short acting B2 agonist medication for symptoms within 14 days of Day 0 of:

• More than 6 doses per day on any one day or

• More than 3 doses per day on 6 or more days

• Any medication other than:

• inhaled short-acting B2 agonist

• inhaled corticosteroids

• topic eczema treatments (with the exception of fluorinated corticosteroid dermatological preparations which are not permitted

• hormone replacement therapy

• vitamin preparation/food supplements

• occasional use of proton pump inhibitors, ranitidine, cimetidine, antacids or over-the-counter analgesics.

• Treatment within 6 months of Day 0 with any of the following: methylxanthines, inhaled cromones, leukotriene modifiers, anti- IgE, anticholinergics, ketotifen, oral short acting B2 agonists, long-acting B2 agonists, oral or injected corticosteroids

• Treatment of atopic symptoms, other than eczema, within 4 weeks of Day 0

• History of medication that might carry-over effects into the study

• Previously received monoclonal antibody, or a similar related protein, that might sensitise to CAT-354

• Participation in another study within three months of the start of the study or 5 half lives of the previously administered investigational medicinal product (IMMP), whichever is longer

• Lower respiratory tract infection within four weeks of Day-14

• Any acute illness in the two weeks before Day 0

• Current smokers, those who have smoked in previous year, and those with smoking history of greater than or equal to 10 pack years

• Considered by the investigator to be at risk of transmitting, through blood, the agents responsible for infectious diseases

• Blood donation (550mls) in the previous 2 months

• Excessive intake of alcohol (more than 21 units a week for females or 28 units a week for males)

• The subject's general practitioner has suggested a reason the subject should not participate in the study

• The Investigator considers the subject should not take part for any reason