Last updated on May 2019

Safety and Tolerability of MEDI3506 in Healthy Subjects in Subjects With COPD and Healthy Japanese Subjects


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Safety | Part II (MAD) - Chronic Obstructive Pulmonary Disease | Part III (J-SD) - Healthy Japanese Subjects | Part I (SAD) - Healthy Subjects
  • Age: Between 18 - 80 Years
  • Gender: Male or Female

Inclusion Criteria Part I (SAD)

  1. Healthy volunteers age 18 through 55 years at the time of consent.
  2. Non-smokers, healthy current smokers, and ex-smokers are permitted.
  3. Pre-bronchodilator FEV1 80% Predicted .
  4. BMI of 19.0 through 32.0 kg/m2 at screening.
  5. Current history of mild atopy.

Inclusion Criteria Part II (MAD)

  1. Age 40 through 80 years at the time of screening.
  2. BMI of 19.0 through 35.0 kg/m^2 at screening.
  3. Subjects must be current on pneumococcus and annual influenza vaccines
  4. Documented history of COPD with a post-bronchodilator FEV1/FVC <0.70 and a post-bronchodilator FEV1 50% predicted at screening.
  5. Clinically stable and free from an acute exacerbation of COPD for 8 weeks prior to Day 1
  6. Current or ex-smoker with a tobacco history of 10 pack-years

Inclusion Criteria Part III (J-SD)

  1. Japanese subjects must have been born in Japan, have both parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years.
  2. Healthy subjects aged 20 through 55 years at the time of consent.
  3. Non-smokers, healthy current smokers, and ex-smokers are permitted.
  4. BMI of 18.0 through 32.0 kg/m^2 at screening

Exclusion Criteria Part I (SAD)

  1. Concurrent enrollment in another clinical study involving an investigational treatment.
  2. Received administration of an investigational drug or participated in a device trial within 3 months, prior to screening (Visit 1)
  3. Subject is a participating investigator, sub-investigator, study coordinator or employee of the participating site, or is a first-degree relative of the aforementioned.
  4. Any active medical or psychiatric condition or other reason which, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study.
  5. Any clinically relevant abnormal findings on physical examination of the cardiovascular system including ECG and vital signs at screening or randomization
  6. Abnormal vital signs, after 10 minutes supine rest

Exclusion Criteria Part II (MAD)

  1. Concurrent enrolment in another clinical study involving investigational treatment
  2. Received administration of an investigational drug or participated in a device trial within 3 months, prior to screening (Visit 1)
  3. Subject is a participating investigator, sub-investigator, study coordinator, or employee of the participating site, or is a first-degree relative of the aforementioned.
  4. Any active medical or psychiatric condition or other reason that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results. This includes, but is not limited
    to
    • Uncontrolled diabetes
    • Hypertension during the screening period
    • Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure
    • Clinically significant Aortic stenosis
    • Pulmonary Arterial Hypertension

Exclusion Criteria Part III (J-SD)

  1. Concurrent enrolment in another clinical study involving an investigational treatment.
  2. Received administration of an investigational drug or participated in a device trial within 3 months, prior to screening (Visit 1).
  3. Any active medical or psychiatric condition or other reason which, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study.
  4. Any clinically relevant abnormal findings on physical examination of the cardiovascular system including ECG and vital signs at screening, and Day 1(pre-dose)
  5. Any other clinically relevant abnormal findings on physical examination or laboratory testing including haematology, coagulation, clinical chemistry or urinalysis at screening or randomisation

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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