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

• 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: MedImmune LLC
• Information provided by (Responsible Party): MedImmune LLC

Tracking Information

• First Submitted Date: March 23, 2011
• First Posted Date: March 24, 2011
• Results First Submitted Date: July 19, 2013
• Results First Posted Date: October 23, 2013
• Last Update Posted Date: October 23, 2013
• Study Start Date: March 2011
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Chronic Obstructive Pulmonary Disease

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 10, 2012): 31
• Original Estimated Enrollment (submitted: March 23, 2011): 30
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: South Africa, United Kingdom

Administrative Information

• NCT Number: NCT01322594
• Other Study ID Numbers: CD-RI-MEDI2338-1033; 2010-022879-54 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: MedImmune LLC
• Original Responsible Party: Edward Piper, MBBS, Senior Director, Clinical Development, MedImmune Ltd
• Current Study Sponsor: MedImmune LLC
• Original Study Sponsor: MedImmune Ltd
• Collaborators: Not Provided

Investigators

• Study Director: Edward Piper, MBBS; MedImmune Ltd

• PRS Account: MedImmune LLC
• Verification Date: October 2013