A Study to Assess Pharmacokinetics, Safety and Tolerability of Multiple Doses of CAT-354 in Subjects With Moderate Asthma

Study identifier:CAT-354-0602

ClinicalTrials.gov identifier:NCT00974675

EudraCT identifier:2006-003199-36

CTIS identifier:N/A

Terminated/Withdrawn

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

Medical condition

Moderate Asthma

Phase

Phase 1

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 29 Sept 2006

Primary Completion Date: 03 Aug 2007

Study Completion Date: 03 Aug 2007

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2017 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- 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 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 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.

No locations available

Arms	Assigned Interventions
Experimental: CAT-354 1 mg/kg CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.	Biological/Vaccine: CAT-354 1mg/kg CAT-354 1 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. Other Name: Tralokinumab
Experimental: CAT-354 5 mg/kg CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.	Biological/Vaccine: CAT-354 5 mg/kg CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. Other Name: Tralokinumab
Experimental: CAT-354 10mg/kg CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.	Biological/Vaccine: CAT-354 10mg/kg CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. Other Name: Tralokinumab
Placebo Comparator: Placebo Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.	Other: Placebo Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

MedImmune LLC

MedImmune