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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322594
• Other study ID #: CD-RI-MEDI2338-1033
• Secondary ID: 2010-022879-54
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2011
• Last updated: October 9, 2013
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2013
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Biological:
• MEDI2338
MEDI2338 single intravenous (IV) dose (lowest dose)
• MEDI2338
MEDI2338 single IV dose (next highest dose)
• MEDI2338
MEDI2338 single IV dose (next highest dose)
• MEDI2338
MEDI2338 single IV dose (next highest dose)
• MEDI2338
MEDI2338 single IV dose (highest dose)

Other:
• Placebo
Placebo single IV dose

Locations

Country	Name	City	State
South Africa	Research Site	Bloemfontein
South Africa	Research Site	George
South Africa	Research Site	Port Elizabeth
United Kingdom	Research Site	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events	Number of participants experiencing adverse events (includes both adverse events and serious adverse events)	Days 1 - 92	Yes
Primary	Incidence of Serious Adverse Events	Number of participants experiencing serious adverse events	Days 1 - 92	Yes
Primary	Incidence of Clinically Significant Hematology Laboratory Results	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.	Days 1 - 92	Yes
Primary	Incidence of Clinically Significant Electrocardiogram Results	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.	Days 1 - 92	Yes
Primary	Incidence of Clinically Significant Vital Signs Results	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.	Days 1 - 92	Yes
Primary	Incidence of Clinically Significant Serum Chemistry Laboratory Results	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.	Days 1 - 92	Yes
Secondary	Area Under the Serum Concentration-Time Curve From Time Zero to Infinity	Area under the serum concentration-time curve from time zerio to infinity of MEDI2338	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)	No
Secondary	Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point	Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338	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)	No
Secondary	Incidence of Anti-drug Antibodies (ADA) to MEDI2338	Number of participants with ADA to MEDI2338	Days 1, 57, and 92	Yes
Secondary	Observed Maximum Concentration (Cmax)	Cmax of MEDI2338	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)	No
Secondary	Apparent Terminal Elimination Phase Half-life (t1/2)	t1/2 of MEDI2338	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)	No
Secondary	Clearance (CL)	CL of MEDI2338	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)	No

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