A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354

Study identifier:CAT-354-0703

ClinicalTrials.gov identifier:NCT00638989

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-Label, Parallel-Group, Bioavailability Study to Assess the Pharmacokinetics of CAT-354 Following Subcutaneous and Intravenous Administration

Medical condition

asthma, Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Sex

Male

Actual Enrollment

Study type

Interventional

Age

19 Years - 55 Years

Date

Study Start Date: 11 Apr 2008

Primary Completion Date: 07 Jun 2008

Study Completion Date: 07 Jun 2008

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2017 by MedImmune, LLC

Collaborators

Inclusion and exclusion 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 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 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 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).

No locations available

Arms	Assigned Interventions
Experimental: CAT-354 150 mg (intravenous) A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.	Biological/Vaccine: CAT-354 150 mg (intravenous) A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. Other Name: Tralokinumab
Experimental: CAT-354 150 mg (subcutaneous) A single dose of CAT-354 150 mg injection subcutaneously on Day 0.	Biological/Vaccine: CAT-354 150 mg (subcutaneous) A single dose of CAT-354 150 mg injection subcutaneously on Day 0. Other Name: Tralokinumab
Experimental: CAT-354 300 mg (subcutaneous) A single dose of CAT-354 300 mg injection subcutaneously on Day 0.	Biological/Vaccine: CAT-354 300 mg (subcutaneous) A single dose of CAT-354 300 mg injection subcutaneously on Day 0. Other Name: Tralokinumab

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