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Completed

NCT Number: NCT01322594

A 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).

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Bloemfontein, South Africa

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MEDI2338

Biological

MEDI2338 single intravenous (IV) dose (lowest dose)

Placebo

Other

Placebo single IV dose

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: Days 1 - 92

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

  2. Incidence of Serious Adverse Events

    Time frame: Days 1 - 92

    Number of participants experiencing serious adverse events

  3. Incidence of Clinically Significant Hematology Laboratory Results

    Time frame: Days 1 - 92

    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.

  4. Incidence of Clinically Significant Electrocardiogram Results

    Time frame: Days 1 - 92

    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.

  5. Incidence of Clinically Significant Vital Signs Results

    Time frame: Days 1 - 92

    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.

  6. Incidence of Clinically Significant Serum Chemistry Laboratory Results

    Time frame: Days 1 - 92

    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.

Secondary outcomes

  1. Area Under the Serum Concentration-Time Curve From Time Zero to Infinity

    Time frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)

    Area under the serum concentration-time curve from time zerio to infinity of MEDI2338

  2. Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point

    Time frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)

    Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338

  3. Incidence of Anti-drug Antibodies (ADA) to MEDI2338

    Time frame: Days 1, 57, and 92

    Number of participants with ADA to MEDI2338

  4. Observed Maximum Concentration (Cmax)

    Time frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)

    Cmax of MEDI2338

  5. Apparent Terminal Elimination Phase Half-life (t1/2)

    Time frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)

    t1/2 of MEDI2338

  6. Clearance (CL)

    Time frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)

    CL of MEDI2338

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase 1, Single Ascending Dose Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 24, 2011
Registry last updated
Oct 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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