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).

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.