A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354

MedImmune

Status and phase: Completed; Phase 1

Conditions: Healthy; Asthma

Treatments: Biological: CAT-354 150 mg (intravenous); Biological: CAT-354 150 mg (subcutaneous); Biological: CAT-354 300 mg (subcutaneous)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00638989

CAT-354-0703

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

CAT-354 150 mg (intravenous)

Experimental group

Description:

A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.

Treatment:

Biological: CAT-354 150 mg (intravenous)

CAT-354 150 mg (subcutaneous)

Experimental group

Description:

A single dose of CAT-354 150 mg injection subcutaneously on Day 0.

Treatment:

Biological: CAT-354 150 mg (subcutaneous)

CAT-354 300 mg (subcutaneous)

Experimental group

Description:

A single dose of CAT-354 300 mg injection subcutaneously on Day 0.

Treatment:

Biological: CAT-354 300 mg (subcutaneous)