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

NCT01322594 | Completed Phase 1 Results

• 2 other identifiers: CD-RI-MEDI2338-10332010-022879-54
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 4

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; COPD

Outcome Measures

Primary Outcomes (6)

• Incidence of Adverse Events

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

  Days 1 - 92

• Incidence of Serious Adverse Events

  Number of participants experiencing serious adverse events

  Days 1 - 92

• 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

• 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

• 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

• 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

Secondary Outcomes (6)

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

  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

  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)

• Incidence of Anti-drug Antibodies (ADA) to MEDI2338

  Days 1, 57, and 92

• Observed Maximum Concentration (Cmax)

  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)

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

  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)

Study Arms (6)

MEDI2338 10 MG

EXPERIMENTAL

MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump

Biological: MEDI2338

MEDI2338 30 MG

EXPERIMENTAL

MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Biological: MEDI2338

MEDI2338 100 MG

EXPERIMENTAL

MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Biological: MEDI2338

MEDI2338 300 MG

EXPERIMENTAL

MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Biological: MEDI2338

MEDI2338 1000 MG

EXPERIMENTAL

MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Biological: MEDI2338

Placebo

PLACEBO COMPARATOR

Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Other: Placebo

Interventions

MEDI2338 BIOLOGICAL

MEDI2338 single intravenous (IV) dose (lowest dose)

MEDI2338 10 MG

Placebo OTHER

Placebo single IV dose

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (4)

Research Site

Bloemfontein, 9300, South Africa

Location

Research Site

George, 6529, South Africa

Location

Research Site

Port Elizabeth, 6045, South Africa

Location

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ed Piper
• Organization: MedImmune, Limited

pipered@medimmune.com

+44 (0) 1223 471 471

Study Officials

• Edward Piper, MBBS

  MedImmune Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 23, 2013
• Results First Posted: October 23, 2013

Record last verified: 2013-10

Locations

ZA (3); GB (1)