Back to resultsA Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MEDI2338
MEDI2338
MEDI2338
MEDI2338
MEDI2338
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, COPD
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.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
MEDI2338 10 MG
MEDI2338 30 MG
MEDI2338 100 MG
MEDI2338 300 MG
MEDI2338 1000 MG
Placebo
Arm Description
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Outcomes
Primary Outcome Measures
Incidence of Adverse Events
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events
Incidence of Clinically Significant Hematology Laboratory Results
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
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
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
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.
Secondary Outcome Measures
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity
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
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
Number of participants with ADA to MEDI2338
Observed Maximum Concentration (Cmax)
Cmax of MEDI2338
Apparent Terminal Elimination Phase Half-life (t1/2)
t1/2 of MEDI2338
Clearance (CL)
CL of MEDI2338
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01322594
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI2338 10 MG
Arm Type
Experimental
Arm Description
MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
Arm Title
MEDI2338 30 MG
Arm Type
Experimental
Arm Description
MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Arm Title
MEDI2338 100 MG
Arm Type
Experimental
Arm Description
MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Arm Title
MEDI2338 300 MG
Arm Type
Experimental
Arm Description
MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Arm Title
MEDI2338 1000 MG
Arm Type
Experimental
Arm Description
MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Intervention Type
Biological
Intervention Name(s)
MEDI2338
Intervention Description
MEDI2338 single intravenous (IV) dose (lowest dose)
Intervention Type
Biological
Intervention Name(s)
MEDI2338
Intervention Description
MEDI2338 single IV dose (next highest dose)
Intervention Type
Biological
Intervention Name(s)
MEDI2338
Intervention Description
MEDI2338 single IV dose (next highest dose)
Intervention Type
Biological
Intervention Name(s)
MEDI2338
Intervention Description
MEDI2338 single IV dose (next highest dose)
Intervention Type
Biological
Intervention Name(s)
MEDI2338
Intervention Description
MEDI2338 single IV dose (highest dose)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo single IV dose
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Time Frame
Days 1 - 92
Title
Incidence of Serious Adverse Events
Description
Number of participants experiencing serious adverse events
Time Frame
Days 1 - 92
Title
Incidence of Clinically Significant Hematology Laboratory Results
Description
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.
Time Frame
Days 1 - 92
Title
Incidence of Clinically Significant Electrocardiogram Results
Description
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.
Time Frame
Days 1 - 92
Title
Incidence of Clinically Significant Vital Signs Results
Description
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.
Time Frame
Days 1 - 92
Title
Incidence of Clinically Significant Serum Chemistry Laboratory Results
Description
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.
Time Frame
Days 1 - 92
Secondary Outcome Measure Information:
Title
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity
Description
Area under the serum concentration-time curve from time zerio to infinity of MEDI2338
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)
Title
Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point
Description
Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338
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)
Title
Incidence of Anti-drug Antibodies (ADA) to MEDI2338
Description
Number of participants with ADA to MEDI2338
Time Frame
Days 1, 57, and 92
Title
Observed Maximum Concentration (Cmax)
Description
Cmax of MEDI2338
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)
Title
Apparent Terminal Elimination Phase Half-life (t1/2)
Description
t1/2 of MEDI2338
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)
Title
Clearance (CL)
Description
CL of MEDI2338
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Piper, MBBS
Organizational Affiliation
MedImmune Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Research Site
City
George
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Research Site
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Research Site
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
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