Trial record 2 of 6 for:    medimmune tralokinumab

A Phase 1 Study to Evaluate the Pharmacokinetics and Tolerability of Tralokinumab When Delivered at Different Flow Rates to Healthy Volunteers

This study is not yet open for participant recruitment.
Verified March 2014 by MedImmune LLC
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02085473
First received: March 11, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

The aim of this study is to evaluate the pharmacokinetics and tolerability of tralokinumab when deliverd at different flow rates to healthy volunteers.


Condition Intervention Phase
Asthma
Biological: tralokinumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of tralokinumab [ Time Frame: Day 1,2,4,6,8,10,15,22,36,57 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain intensity, measured using 100mm Visual Analogue Scale (VAS) [ Time Frame: Day 1 to 57 ] [ Designated as safety issue: Yes ]
  • Number of injection site reactions [ Time Frame: Day 1 to 57 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Two subcutaneous injections at flow rate 1
Biological: tralokinumab
Subcutaneous Injection
Experimental: Cohort 2
Single subcutaneous injection at flow rate 2
Biological: tralokinumab
Subcutaneous Injection
Experimental: Cohort 3
Single subcutaneous injection at flow rate 3
Biological: tralokinumab
Subcutaneous Injection
Experimental: Cohort 4
Single subcutaneous injection at flow rate 4
Biological: tralokinumab
Subcutaneous Injection

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Healthy males and females ages 19-65 years
  • Body mass index of 19.0-30.0 kg/m2
  • No clinically significant abnormality
  • Vital signs, electrocardiogram (ECG), and laboratory parameters within normal range
  • Negative alcohol and drug screens
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception
  • Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective contraception

Key Exclusion Criteria:

  • Concurrent enrollment in another clinical study where the subject is receiving an investigational product
  • Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer
  • Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
  • Current use of regular pain-modifying, anti-depressant, anxiolytic, or hypnotic medication
  • History of thrombocytopenia or bleeding disorder or use of anticoagulants
  • History of any immunodeficiency disorder or use of immunosuppressive medication.
  • History of a clinically significant infection
  • History of cancer
  • Hepatitis B or C
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02085473

Contacts
Contact: MedImmune Contact ClinicalTrialEnquiries@Medimmune.com

Locations
United States, Nebraska
Celerion Not yet recruiting
Lincoln, Nebraska, United States, 68502
Research Site Not yet recruiting
Lincoln, Nebraska, United States
Sponsors and Collaborators
MedImmune LLC
Investigators
Principal Investigator: Barbara Cook, MD Celerion
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02085473     History of Changes
Other Study ID Numbers: D2210C00011
Study First Received: March 11, 2014
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014