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A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01322594
Recruitment Status : Completed
First Posted : March 24, 2011
Results First Posted : October 23, 2013
Last Update Posted : October 23, 2013
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE March 23, 2011
First Posted Date  ICMJE March 24, 2011
Results First Submitted Date  ICMJE July 19, 2013
Results First Posted Date  ICMJE October 23, 2013
Last Update Posted Date October 23, 2013
Study Start Date  ICMJE March 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
  • Incidence of Adverse Events [ Time Frame: Days 1 - 92 ]
    Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
  • Incidence of Serious Adverse Events [ Time Frame: Days 1 - 92 ]
    Number of participants experiencing serious adverse events
  • Incidence of Clinically Significant Hematology Laboratory Results [ Time Frame: Days 1 - 92 ]
    Number of participants experiencing clinically significant hematology laboratory results. A clinically significant hematology laboratory result is defined as an abnormal hematology laboratory result that results in a treatment-emergent adverse event.
  • Incidence of Clinically Significant Electrocardiogram Results [ Time Frame: Days 1 - 92 ]
    Number of participants experiencing clinically significant electrocardiogram results. A clinically significant electrocardiogram result is defined as an abnormal electrocardiogram result that results in a treatment-emergent adverse event.
  • Incidence of Clinically Significant Vital Signs Results [ Time Frame: Days 1 - 92 ]
    Number of participants experiencing clinically significant vital signs results. A clinically significant vital signs result is defined as an abnormal vital signs result that results in a treatment-emergent adverse event.
  • Incidence of Clinically Significant Serum Chemistry Laboratory Results [ Time Frame: Days 1 - 92 ]
    Number of participants experiencing clinically significant serum chemistry laboratory results. A clinically significant serum chemistry laboratory result is defined as an abnormal serum chemistry laboratory result that results in a treatment-emergent adverse event.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
  • Safety variables (adverse events) [ Time Frame: Days 1 - 92 ]
  • Safety variables (serious adverse events) [ Time Frame: Days 1 - 92 ]
  • Safety variables (clinical laboratory assessments) [ Time Frame: Days 1 - 92 ]
  • Safety variables (electrocardiogram) [ Time Frame: Days 1 - 92 ]
  • Safety variables (vital signs) [ Time Frame: Days 1 - 92 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
  • Area Under the Serum Concentration-Time Curve From Time Zero to Infinity [ Time Frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92) ]
    Area under the serum concentration-time curve from time zerio to infinity of MEDI2338
  • Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point [ Time Frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92) ]
    Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338
  • Incidence of Anti-drug Antibodies (ADA) to MEDI2338 [ Time Frame: Days 1, 57, and 92 ]
    Number of participants with ADA to MEDI2338
  • Observed Maximum Concentration (Cmax) [ Time Frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92) ]
    Cmax of MEDI2338
  • Apparent Terminal Elimination Phase Half-life (t1/2) [ Time Frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92) ]
    t1/2 of MEDI2338
  • Clearance (CL) [ Time Frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92) ]
    CL of MEDI2338
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
  • Pharmacokinetics serum concentration of MEDI2338 [ Time Frame: Days 1 - 92 ]
  • Pharmacokinetics (AUC, Cmax, t1/2, CL) [ Time Frame: Day 1 ]
  • Presence of anti-drug antibodies against MEDI2338 [ Time Frame: Days 1 - 92 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
Official Title  ICMJE A Phase 1, Single Ascending Dose Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
Brief Summary Phase I study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI2338 in subjects with stable, mild to moderate chronic obstructive pulmonary disease (COPD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Biological: MEDI2338
    MEDI2338 single intravenous (IV) dose (lowest dose)
  • Biological: MEDI2338
    MEDI2338 single IV dose (next highest dose)
  • Biological: MEDI2338
    MEDI2338 single IV dose (highest dose)
  • Other: Placebo
    Placebo single IV dose
Study Arms  ICMJE
  • Experimental: MEDI2338 10 MG
    MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
    Intervention: Biological: MEDI2338
  • Experimental: MEDI2338 30 MG
    MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
    Intervention: Biological: MEDI2338
  • Experimental: MEDI2338 100 MG
    MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
    Intervention: Biological: MEDI2338
  • Experimental: MEDI2338 300 MG
    MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
    Intervention: Biological: MEDI2338
  • Experimental: MEDI2338 1000 MG
    MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
    Intervention: Biological: MEDI2338
  • Placebo Comparator: Placebo
    Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2012)
31
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2011)
30
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged ≥ 40 years at time of screening.
  • Females of non-childbearing potential defined as surgically sterile or at least 2 years postmenopausal.
  • Males, unless surgically sterile, must use 2 highly effective methods of birth control from screening through end of trial.
  • A diagnosis of mild to moderate COPD.
  • Cigarette smoking history of ≥10 pack years.
  • Ability to understand and comply with protocol requirements, instructions and restrictions.
  • COPD symptoms adequately controlled on a therapeutic regimen that has not changed in the 4 weeks prior to screening.

Exclusion Criteria:

  • Current diagnosis of any respiratory condition other than COPD.
  • Active or history of any disease or condition that would, in the opinion of the investigator and/or medical monitor, place the subject at an unacceptable risk to participate in this study.
  • History of or suspected history of alcohol misuse or recreational substance abuse.
  • Treatment with oral or IV corticosteroids within 8 weeks prior to screening.
  • Concurrent enrolment in another clinical study.
  • Receipt of any investigational drug therapy of use of any biologicals within 6 months prior to screening.
  • Known history of allergy or reaction to any component of the investigational product.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01322594
Other Study ID Numbers  ICMJE CD-RI-MEDI2338-1033
2010-022879-54 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party MedImmune LLC
Original Responsible Party Edward Piper, MBBS, Senior Director, Clinical Development, MedImmune Ltd
Current Study Sponsor  ICMJE MedImmune LLC
Original Study Sponsor  ICMJE MedImmune Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Edward Piper, MBBS MedImmune Ltd
PRS Account MedImmune LLC
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP