A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease - Full Text View

Purpose

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).

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Biological: MEDI2338 Other: Placebo	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Phase 1, Single Ascending Dose Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

MedlinePlus related topics: COPD Lung Diseases

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Incidence of Adverse Events [ Time Frame: Days 1 - 92 ] [ Designated as safety issue: Yes ]
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Incidence of Serious Adverse Events [ Time Frame: Days 1 - 92 ] [ Designated as safety issue: Yes ]
Number of participants experiencing serious adverse events
Incidence of Clinically Significant Hematology Laboratory Results [ Time Frame: Days 1 - 92 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 [ 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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
CL of MEDI2338


Enrollment:	31
Study Start Date:	March 2011
Study Completion Date:	December 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Biological: MEDI2338 MEDI2338 single intravenous (IV) dose (lowest dose)
Experimental: MEDI2338 30 MG MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump	Biological: MEDI2338 MEDI2338 single IV dose (next highest dose)
Experimental: MEDI2338 100 MG MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump	Biological: MEDI2338 MEDI2338 single IV dose (next highest dose)
Experimental: MEDI2338 300 MG MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump	Biological: MEDI2338 MEDI2338 single IV dose (next highest dose)
Experimental: MEDI2338 1000 MG MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump	Biological: MEDI2338 MEDI2338 single IV dose (highest dose)
Placebo Comparator: Placebo Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump	Other: Placebo Placebo single IV dose

Eligibility


Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322594

Locations


South Africa
Research Site
Bloemfontein, South Africa, 9300
Research Site
George, South Africa, 6529
Research Site
Port Elizabeth, South Africa, 6045
United Kingdom
Research Site
Harrow, United Kingdom, HA1 3UJ

Sponsors and Collaborators

MedImmune LLC

Investigators


Study Director:	Edward Piper, MBBS	MedImmune Ltd

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT01322594 History of Changes
Other Study ID Numbers:	CD-RI-MEDI2338-1033, 2010-022879-54
Study First Received:	March 23, 2011
Results First Received:	July 19, 2013
Last Updated:	October 9, 2013
Health Authority:	South Africa: Medicines Control Council United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by MedImmune LLC:


Chronic Obstructive Pulmonary Disease COPD

Additional relevant MeSH terms:


Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 03, 2015