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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Placebo; Biological: MEDI2338

Study type: Interventional

Funder types: Industry

Identifiers

NCT01322594

CD-RI-MEDI2338-1033

2010-022879-54 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 31 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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31 participants in 6 patient groups, including a placebo group

MEDI2338 10 MG

Experimental group

Description:

MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump

Treatment:

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

MEDI2338 30 MG

Experimental group

Description:

MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Treatment:

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

MEDI2338 100 MG

Experimental group

Description:

MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Treatment:

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

MEDI2338 300 MG

Experimental group

Description:

MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Treatment:

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

MEDI2338 1000 MG

Experimental group

Description:

MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Treatment:

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

Biological: MEDI2338

Placebo

Placebo Comparator group

Description:

Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Treatment:

Other: Placebo