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

A Phase 1, Single Ascending Dose Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Biological: MEDI2338; Biological: MEDI2338; Biological: MEDI2338; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / 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); Biological: MEDI2338; MEDI2338 single IV dose (next highest dose); Biological: MEDI2338; MEDI2338 single IV dose (highest 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 intravenous (IV) dose (lowest dose); Biological: MEDI2338; MEDI2338 single IV dose (next highest dose); Biological: MEDI2338; MEDI2338 single IV dose (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 intravenous (IV) dose (lowest dose); Biological: MEDI2338; MEDI2338 single IV dose (next highest dose); Biological: MEDI2338; MEDI2338 single IV dose (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 intravenous (IV) dose (lowest dose); Biological: MEDI2338; MEDI2338 single IV dose (next highest dose); Biological: MEDI2338; MEDI2338 single IV dose (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 intravenous (IV) dose (lowest dose); Biological: MEDI2338; MEDI2338 single IV dose (next highest dose); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Number of participants experiencing adverse events (includes both adverse events and serious adverse events)	Days 1 - 92
Incidence of Serious Adverse Events	Number of participants experiencing serious adverse events	Days 1 - 92
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.	Days 1 - 92
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.	Days 1 - 92
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.	Days 1 - 92
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.	Days 1 - 92

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338	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)
Incidence of Anti-drug Antibodies (ADA) to MEDI2338	Number of participants with ADA to MEDI2338	Days 1, 57, and 92
Observed Maximum Concentration (Cmax)	Cmax of MEDI2338	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)
Apparent Terminal Elimination Phase Half-life (t1/2)	t1/2 of MEDI2338	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)
Clearance (CL)	CL of MEDI2338	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)

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Investigators: Study Director: Edward Piper, MBBS, MedImmune Ltd

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: March 23, 2011
• First Submitted That Met QC Criteria: March 23, 2011
• First Posted (Estimate): March 24, 2011

Study Record Updates

• Last Update Posted (Estimate): October 23, 2013
• Last Update Submitted That Met QC Criteria: October 9, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CD-RI-MEDI2338-1033; 2010-022879-54 (EudraCT Number)