A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354

MedImmune LLC30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma Healthy

Interventions

CAT-354 150 mg (intravenous)BIOLOGICAL

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

CAT-354 150 mg (subcutaneous)BIOLOGICAL

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

CAT-354 300 mg (subcutaneous)BIOLOGICAL

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

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

MDS Pharma Services (US) Inc.

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Absolute Bioavailability of CAT-354 After Subcutaneous Dose

Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC \[0 - infinity\]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).

Time frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56

Secondary Outcomes

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 56 that were absent before treatment or that worsened relative to pre-treatment state.

Time frame: Day 0 to 56

Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit

Time frame: Day 0 and Day 56

Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity])

AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).

Time frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56

Data from ClinicalTrials.gov

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