Clinical trial NCT01322594: A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
Official title: A Phase 1, Single Ascending Dose Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2011-03-24
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility 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.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Days 1 - 92
measure: Incidence of Serious Adverse Events
timeFrame: Days 1 - 92
measure: Incidence of Clinically Significant Hematology Laboratory Results
timeFrame: Days 1 - 92
measure: Incidence of Clinically Significant Electrocardiogram Results
timeFrame: Days 1 - 92
measure: Incidence of Clinically Significant Vital Signs Results
timeFrame: Days 1 - 92
measure: Incidence of Clinically Significant Serum Chemistry Laboratory Results
timeFrame: Days 1 - 92
Secondary outcomes:
measure: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity
timeFrame: 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)
measure: Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point
timeFrame: 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)
measure: Incidence of Anti-drug Antibodies (ADA) to MEDI2338
timeFrame: Days 1, 57, and 92
measure: Observed Maximum Concentration (Cmax)
timeFrame: 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)
measure: Apparent Terminal Elimination Phase Half-life (t1/2)
timeFrame: 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)
measure: Clearance (CL)
timeFrame: 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)
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: Research Site
city: George
country: South Africa
facility: Research Site
city: Port Elizabeth
country: South Africa
facility: Research Site
city: Harrow
country: United Kingdom
facility: Research Site
Study officials:
affiliation: MedImmune Ltd
name: Edward Piper, MBBS
role: STUDY_DIRECTOR
References: