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

MedImmune LLC31 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

MEDI2338BIOLOGICAL

MEDI2338 single intravenous (IV) dose (lowest dose)

MEDI2338BIOLOGICAL

MEDI2338 single IV dose (next highest dose)

MEDI2338BIOLOGICAL

MEDI2338 single IV dose (next highest dose)

MEDI2338

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (4)

Research Site

Bloemfontein, South Africa

Research Site

George, South Africa

Research Site

Port Elizabeth, South Africa

Research Site

Harrow, United Kingdom

Outcomes

Primary Outcomes

Incidence of Adverse Events

Number of participants experiencing adverse events (includes both adverse events and serious adverse events)

Time frame: Days 1 - 92

Incidence of Serious Adverse Events

Number of participants experiencing serious adverse events

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Days 1 - 92

Data from ClinicalTrials.gov

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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