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

Phase 1

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Biological: MEDI2338
Other: Placebo

Registration Number: NCT01322594

Lead Sponsor: MedImmune LLC

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MEDI2338 100 MG	MEDI2338	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 10 MG	MEDI2338	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Primary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events	Days 1 - 92	Number of participants experiencing serious adverse events
Incidence of Clinically Significant Electrocardiogram Results	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	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	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.
Incidence of Adverse Events	Days 1 - 92	Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Incidence of Clinically Significant Hematology Laboratory Results	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.

Secondary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity	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	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	Days 1, 57, and 92	Number of participants with ADA to MEDI2338
Observed Maximum Concentration (Cmax)	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)	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)	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