A Study to Assess Bioavailability and Pharmacokinetics of CAT 354 - Full Text View

Sponsored by:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00638989

Purpose

To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with IV administration.

Condition	Intervention	Phase
Healthy	Drug: CAT-354	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	An Open-Label, Parallel-Group, Bioavailability Study to Assess the Pharmacokinetics of CAT-354 Following Subcutaneous and Intravenous Administration

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Bioavailability and PK of CAT-354 following subcutaneous administration of 150 mg and 300 mg compared with 150 mg given intravenously. [ Time Frame: waiting on response ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess safety and tolerability of subcutaneous administration of CAT-354. [ Time Frame: waiting on response ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	March 2008
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental CAT-354	Drug: CAT-354 CAT-354 following subcutaneous administration of 150 mg and 300 mg
2: Experimental CAT-354	Drug: CAT-354 CAT-354 following intravenous administration of 150 mg

Detailed Description:

To compare the bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration of 150 mg and 300 mg compared with 150 mg given intravenously.

Eligibility

Ages Eligible for Study:	19 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 ECG (no clinically significant abnormalities).
Clinical chemistry, hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator (see Section 11.7 of the protocol for explanation on tests to be performed).
A negative screen for drugs of abuse and alcohol.
Body mass index (BMI) between 18-30 kg/m2, inclusive.
No other clinically significant abnormality on history and clinical examination (see also Exclusion Criteria).
Able to comply with the requirements of the protocol.

Exclusion Criteria:

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 three months of the start of this study or five 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 two 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 HIV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638989

Contacts

Contact: Nestor Molfino, M.D.	301-398-0000
Contact: Lenny Smith	301-398-0000

Locations

United States, Nebraska
MDS Pharma Services (US) Inc.
Lincoln, Nebraska, United States, 68502

Sponsors and Collaborators

MedImmune LLC

Investigators

Principal Investigator:

James C. Kisicki, M.D.

MDS Pharma Services

More Information

Responsible Party:	MedImmune ( Nestor Molfino, M.D. )
Study ID Numbers:	CAT-354-0703
Study First Received:	March 12, 2008
Last Updated:	March 18, 2008
ClinicalTrials.gov Identifier:	NCT00638989
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009