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

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).

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Biological: MEDI2338; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• 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
• Study Start Date: March 2011
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Incidence of Adverse Events [ Time Frame: Days 1 - 92 ]
   Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
2. Incidence of Serious Adverse Events [ Time Frame: Days 1 - 92 ]
   Number of participants experiencing serious adverse events
3. 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.
4. 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.
5. 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.
6. 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.

Secondary Outcome Measures :

1. 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
2. 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
3. Incidence of Anti-drug Antibodies (ADA) to MEDI2338 [ Time Frame: Days 1, 57, and 92 ]
   Number of participants with ADA to MEDI2338
4. 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
5. 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
6. 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

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: MedImmune LLC
• ClinicalTrials.gov Identifier: NCT01322594
• Other Study ID Numbers: CD-RI-MEDI2338-1033; 2010-022879-54 ( EudraCT Number )
• First Posted: March 24, 2011
• Results First Posted: October 23, 2013
• Last Update Posted: October 23, 2013
• Last Verified: October 2013

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