A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354

NCT00638989 | Completed Phase 1 Results

• 1 other identifier: CAT-354-0703
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma; Healthy

Keywords

Asthma; CAT-354; Tralokinumab; Healthy

Outcome Measures

Primary Outcomes (1)

• 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).

  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 (12)

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

  Day 0 to 56

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

  Day 0 and Day 56

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

  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

• Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56])

  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

• Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose)

  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

Study Arms (3)

CAT-354 150 mg (intravenous)

EXPERIMENTAL

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

Biological: CAT-354 150 mg (intravenous)

CAT-354 150 mg (subcutaneous)

EXPERIMENTAL

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

Biological: CAT-354 150 mg (subcutaneous)

CAT-354 300 mg (subcutaneous)

EXPERIMENTAL

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

Biological: CAT-354 300 mg (subcutaneous)

Interventions

CAT-354 150 mg (intravenous) BIOLOGICAL

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

Also known as: Tralokinumab

CAT-354 150 mg (intravenous)

CAT-354 150 mg (subcutaneous) BIOLOGICAL

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

Also known as: Tralokinumab

CAT-354 150 mg (subcutaneous)

CAT-354 300 mg (subcutaneous) BIOLOGICAL

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

Also known as: Tralokinumab

CAT-354 300 mg (subcutaneous)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

MDS Pharma Services (US) Inc.

Lincoln, Nebraska, 68502, United States

Location

Related Publications (1)

• Oh CK, Faggioni R, Jin F, Roskos LK, Wang B, Birrell C, Wilson R, Molfino NA. An open-label, single-dose bioavailability study of the pharmacokinetics of CAT-354 after subcutaneous and intravenous administration in healthy males. Br J Clin Pharmacol. 2010 Jun;69(6):645-55. doi: 10.1111/j.1365-2125.2010.03647.x.

  PMID: 20565456 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

tralokinumab; Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Meena Jain, MB BChir/Associate Medical Director
• Organization: MedImmune, LLC

jainm@medimmune.com

301-398-0000

Study Officials

• MedImmune LLC

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: April 11, 2008
• Primary Completion: June 7, 2008
• Study Completion: June 7, 2008
• Last Updated: May 4, 2017
• Results First Posted: May 4, 2017

Record last verified: 2017-03

Locations

US (1)