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

Asthma Clinical Trial

Official title:

A Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Intravenous Doses of 3 Dose Levels of CAT-354 in Subjects With Moderate Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974675
• Other study ID #: CAT-354-0602
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2009
• Last updated: September 9, 2009
• Start date: September 2006
• Est. completion date: October 2007

Study information

• Verified date: September 2009
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a randomised, double-blind, placebo controlled study. Following confirmation of eligibility, subjects with moderate asthma will be recruited sequentially to one of three dose groups and randomly assigned within dose group to either CAT-354 or placebo. Doses of the assigned treatment will be administered on three occasions 28 days apart. Follow up for pharmacokinetic blood sampling and safety will continue to Day 147 post first dose (91 days post third dose).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CAT-354-0602
1, 5 and 10 mg/kg - Day 0,28, and 56
• Placebo
1,5, and 10 kg - Day 0, 28, and 56

Locations

Country	Name	City	State
United Kingdom	Chiltern International Limited	Slough	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics Assessment: Individual serum concentration profiles for CAT-354 will be generated for each subject.		Day 162	Yes
Secondary	Safety and Tolerability Analysis based on safety population. (e.g., vital signs, lung function, ECG results, haematology, chemistry and normal ranges)		Day 162	Yes