Status:
COMPLETED
A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354
Lead Sponsor:
MedImmune LLC
Conditions:
Asthma
Healthy
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with intravenous administration.
Detailed Description
To compare the bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration of 150 milligram (mg) and 300 mg compared with 150 mg given intravenously.
Eligibility Criteria
Inclusion
- Signed and dated written informed consent is obtained prior to any study related procedure taking place
- Males, aged 19-55 years
- No significant abnormality on clinical examination or medical history (excluding atopic skin signs, symptoms and history)
- A normal 12-lead electrocardiogram (ECG) (no clinically significant abnormalities)
- 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 mass index (BMI) between 18-30 kilogram per square meter (kg/m\^2), inclusive
- No other clinically significant abnormality on history and clinical examination
- Able to comply with the requirements of the protocol.
Exclusion
- Any active concomitant disease including psychological disorders
- History of medication that might carry over effects into study
- Previously received monoclonal antibody, or a similar related protein, that might sensitize subjects to CAT-354
- Participation in another investigational medicinal product study within 3 months of the start of this study or 5 half-lives of the previously administered investigational medicinal product (IMP), whichever is the longer except methodological studies in which no IMP was given
- Any acute illness in the 2 weeks before Day 0 (Visit 2)
- Any blood donation or significant loss of blood within 56 days of study initiation or plasma donation within 7 days of study initiation
- Subject is a participating Investigator, sub-Investigator, study coordinator, or employee of a participating Investigator, or is a first degree relative of the aforementioned
- Any factor which, in the opinion of the Investigator, would jeopardize the evaluation or safety or be associated with poor adherence to the protocol
- The subject's primary care physician recommends the subject should not take part in the study
- Subjects with immunodeficiency disorders
- Subjects who have a positive test for, or have been treated for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
Key Trial Info
Start Date :
April 11 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00638989
Start Date
April 11 2008
End Date
June 7 2008
Last Update
May 4 2017
Active Locations (1)
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1
MDS Pharma Services (US) Inc.
Lincoln, Nebraska, United States, 68502