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

• Safety variables (adverse events) [ Time Frame: Days 1 - 92 ] [ Designated as safety issue: Yes ]
• Safety variables (serious adverse events) [ Time Frame: Days 1 - 92 ] [ Designated as safety issue: Yes ]
• Safety variables (clinical laboratory assessments) [ Time Frame: Days 1 - 92 ] [ Designated as safety issue: Yes ]
• Safety variables (electrocardiogram) [ Time Frame: Days 1 - 92 ] [ Designated as safety issue: Yes ]
• Safety variables (vital signs) [ Time Frame: Days 1 - 92 ] [ Designated as safety issue: Yes ]

• Pharmacokinetics serum concentration of MEDI2338 [ Time Frame: Days 1 - 92 ] [ Designated as safety issue: No ]
• Pharmacokinetics (AUC, Cmax, t1/2, CL) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
• Presence of anti-drug antibodies against MEDI2338 [ Time Frame: Days 1 - 92 ] [ Designated as safety issue: No ]

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).

• Drug: MEDI2338
  MEDI2338 single IV dose (lowest dose)
• Drug: MEDI2338
  MEDI2338 single IV dose (next highest dose)
• Drug: MEDI2338
  MEDI2338 single IV dose (next highest dose) Placebo single IV dose
• Drug: MEDI2338
  MEDI2338 single IV dose (highest dose) Placebo single IV dose

• Experimental: MEDI2338 - Cohort 1
  Dose Cohort 1
  Intervention: Drug: MEDI2338
• Experimental: MEDI2338 - Cohort 2
  Dose Cohort 2
  Intervention: Drug: MEDI2338
• Experimental: MEDI2338 and Placebo - Cohort 3
  Dose Cohort 3
  Intervention: Drug: MEDI2338
• Experimental: MEDI2338 and Placebo - Cohort 4
  Dose Cohort 4
  Intervention: Drug: MEDI2338
• Experimental: MEDI2338 and Placebo - Cohort 5
  Dose Cohort 5
  Intervention: Drug: MEDI2338

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.