MedDataX Logo

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

NCT ID: NCT01322594

Last Updated: 2013-10-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Chronic Obstructive Pulmonary Disease COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MEDI2338 10 MG

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

Group Type EXPERIMENTAL

MEDI2338

Intervention Type BIOLOGICAL

MEDI2338 single intravenous (IV) dose (lowest dose)

MEDI2338 30 MG

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

Group Type EXPERIMENTAL

MEDI2338

Intervention Type BIOLOGICAL

MEDI2338 single IV dose (next highest dose)

MEDI2338 100 MG

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

Group Type EXPERIMENTAL

MEDI2338

Intervention Type BIOLOGICAL

MEDI2338 single IV dose (next highest dose)

MEDI2338 300 MG

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

Group Type EXPERIMENTAL

MEDI2338

Intervention Type BIOLOGICAL

MEDI2338 single IV dose (next highest dose)

MEDI2338 1000 MG

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

Group Type EXPERIMENTAL

MEDI2338

Intervention Type BIOLOGICAL

MEDI2338 single IV dose (highest dose)

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo single IV dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MEDI2338

MEDI2338 single intravenous (IV) dose (lowest dose)

Intervention Type BIOLOGICAL

MEDI2338

MEDI2338 single IV dose (next highest dose)

Intervention Type BIOLOGICAL

MEDI2338

MEDI2338 single IV dose (next highest dose)

Intervention Type BIOLOGICAL

MEDI2338

MEDI2338 single IV dose (next highest dose)

Intervention Type BIOLOGICAL

MEDI2338

MEDI2338 single IV dose (highest dose)

Intervention Type BIOLOGICAL

Placebo

Placebo single IV dose

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Edward Piper, MBBS

Role: STUDY_DIRECTOR

MedImmune Ltd

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Bloemfontein, , South Africa

Site Status

Research Site

George, , South Africa

Site Status

Research Site

Port Elizabeth, , South Africa

Site Status

Research Site

Harrow, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Africa United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-022879-54

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CD-RI-MEDI2338-1033

Identifier Type: -

Identifier Source: org_study_id