A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
This study has been completed.
Sponsor:
MedImmune LLC
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01322594
First received: March 23, 2011
Last updated: August 23, 2012
Last verified: August 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: MEDI2338 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Phase 1, Single Ascending Dose Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease |
Resource links provided by NLM:
Further study details as provided by MedImmune LLC:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 31 |
| Study Start Date: | March 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MEDI2338 - Cohort 1
Dose Cohort 1
|
Drug: MEDI2338
MEDI2338 single IV dose (lowest dose)
|
|
Experimental: MEDI2338 - Cohort 2
Dose Cohort 2
|
Drug: MEDI2338
MEDI2338 single IV dose (next highest dose)
|
|
Experimental: MEDI2338 and Placebo - Cohort 3
Dose Cohort 3
|
Drug: MEDI2338
MEDI2338 single IV dose (next highest dose) Placebo single IV dose
|
|
Experimental: MEDI2338 and Placebo - Cohort 4
Dose Cohort 4
|
Drug: MEDI2338
MEDI2338 single IV dose (next highest dose) Placebo single IV dose
|
|
Experimental: MEDI2338 and Placebo - Cohort 5
Dose Cohort 5
|
Drug: MEDI2338
MEDI2338 single IV dose (highest dose) Placebo single IV dose
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322594
Locations
| South Africa | |
| Research Site | |
| Bloemfontein, South Africa, 9300 | |
| Research Site | |
| George, South Africa, 6529 | |
| Research Site | |
| Port Elizabeth, South Africa, 6045 | |
| United Kingdom | |
| Research Site | |
| Harrow, United Kingdom, HA1 3UJ | |
Sponsors and Collaborators
MedImmune LLC
Investigators
| Study Director: | Edward Piper, MBBS | MedImmune Ltd |
More Information
Additional Information:
No publications provided
| Responsible Party: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT01322594 History of Changes |
| Other Study ID Numbers: | CD-RI-MEDI2338-1033, 2010-022879-54 |
| Study First Received: | March 23, 2011 |
| Last Updated: | August 23, 2012 |
| Health Authority: | South Africa: Medicines Control Council United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by MedImmune LLC:
|
Chronic Obstructive Pulmonary Disease COPD |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013