A Study to Assess Bioavailability and Pharmacokinetics of CAT 354
This study has been completed.
Information provided by:
First received: March 12, 2008
Last updated: March 5, 2009
Last verified: March 2009
To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with IV administration.
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-Label, Parallel-Group, Bioavailability Study to Assess the Pharmacokinetics of CAT-354 Following Subcutaneous and Intravenous Administration
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2008 (Final data collection date for primary outcome measure)
CAT-354 following subcutaneous administration of 150 mg and 300 mg
Other Name: (Anti-IL-13 HuMab)
CAT-354 following intravenous administration of 150 mg
Other Name: (Anti-IL-13 HuMab)
To compare the bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration of 150 mg and 300 mg compared with 150 mg given intravenously.
|Ages Eligible for Study:
||19 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638989
|MDS Pharma Services (US) Inc.
|Lincoln, Nebraska, United States, 68502 |
||James C. Kisicki, M.D.
||MDS Pharma Services
No publications provided
ClinicalTrials.gov processed this record on July 22, 2014
||Nestor Molfino, M.D., MedImmune
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 12, 2008
||March 5, 2009
||United States: Food and Drug Administration