Expired Study
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Lincoln, Nebraska 68502


Purpose:

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


Study summary:

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


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


NCT ID:

NCT00638989


Primary Contact:

Principal Investigator
James C. Kisicki, M.D.
MDS Pharma Services


Backup Contact:

N/A


Location Contact:

Lincoln, Nebraska 68502
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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