Status:
TERMINATED
A Study to Assess Pharmacokinetics, Safety and Tolerability of Multiple Doses of CAT-354 in Subjects With Moderate Asthma
Lead Sponsor:
MedImmune LLC
Conditions:
Moderate Asthma
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The study includes participants with moderate asthma who were randomly assigned to receive the study medication (CAT-354) or placebo.
Detailed Description
This study is a randomized, double-blind, placebo controlled study. Following confirmation of eligibility, subjects with moderate asthma will be recruited sequentially to one of three dose groups and ...
Eligibility Criteria
Inclusion
- Males or infertile females
- Subjects with asthma, well controlled on inhaled corticosteroid and taken as required (PRN) short acting beta 2 agonist therapy only
- Unchanged dose of inhaled corticosteroid for 3 months prior to Day 0 and no expected need for change in dose during study
- Forced expiratory volume in 1 second (FEV1) greater than or equal to 80% predicted at Screening (Baseline)
- 18-60 years
- General Practitioner diagnosis of asthma of 1 year's minimum 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 50-120 kg
- Subjects aged between 18-40 years inclusive must have body mass index (BMI) 18-32 kilogram per square meter (kg/m\^2) inclusive. Subjects aged between 41-60 years must have BMI between 18-30 kg/m\^2 inclusive.
Exclusion
- 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 beta 2 agonist medication for symptoms within 14 days of Day 0 of: More than 6 doses per day on any 1 day or more than 3 doses per day on 6 or more days
- Any medication other than: inhaled short-acting beta 2 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- immunoglobulin E (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 sensitize 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 (IMP), whichever is longer
- Lower respiratory tract infection within 4 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 (550 ml) 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.
Key Trial Info
Start Date :
September 29 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2007
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00974675
Start Date
September 29 2006
End Date
August 3 2007
Last Update
May 2 2017
Active Locations (1)
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1
Chiltern International Limited
Slough, Berkshire, United Kingdom, SL1 2AD