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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022879-54 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| MEDI2338 30 MG | Experimental | MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
|
| MEDI2338 100 MG | Experimental | MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
|
| MEDI2338 300 MG | Experimental | MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
|
| MEDI2338 1000 MG | Experimental | MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
|
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI2338 | Biological | MEDI2338 single intravenous (IV) dose (lowest dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Piper, MBBS | MedImmune Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bloemfontein | 9300 | South Africa | |||
| Research Site |
Eligibile participants in the 10 and 30 mg dose groups received MEDI2338 in an open-label manner. Eligible participants in the 100, 300, and 1000 dose groups were randomized in a 3:1 ratio to receive MEDI2338 or placebo.
A total of 31 participants provided written informed consent and participated in the study at 3 sites in South Africa (2 sites) and the United Kingdom (1 site) between 24Feb2011 and 25Nov2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| FG001 | MEDI2338 10 MG | MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump |
| FG002 | MEDI2338 30 MG | MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| FG003 | MEDI2338 100 MG | MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| FG004 | MEDI2338 300 MG | MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| FG005 | MEDI2338 1000 MG | MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| BG001 | MEDI2338 10 MG | MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adverse Events | Number of participants experiencing adverse events (includes both adverse events and serious adverse events) | All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis | Posted | Number | Participants | Days 1 - 92 |
|
Days 1-92
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ed Piper | MedImmune, Limited | +44 (0) 1223 471 471 | pipered@medimmune.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Placebo Comparator |
Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
|
| MEDI2338 |
| Biological |
MEDI2338 single IV dose (next highest dose) |
|
| MEDI2338 | Biological | MEDI2338 single IV dose (next highest dose) |
|
| MEDI2338 | Biological | MEDI2338 single IV dose (next highest dose) |
|
| MEDI2338 | Biological | MEDI2338 single IV dose (highest dose) |
|
| Placebo | Other | Placebo single IV dose |
|
| Days 1 - 92 |
| 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) |
| Incidence of Anti-drug Antibodies (ADA) to MEDI2338 | Number of participants with ADA to MEDI2338 | Days 1, 57, and 92 |
| 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) |
| 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) |
| 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) |
| George |
| 6529 |
| South Africa |
| Research Site | Port Elizabeth | 6045 | South Africa |
| Research Site | Harrow | HA1 3UJ | United Kingdom |
| BG002 | MEDI2338 30 MG | MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| BG003 | MEDI2338 100 MG | MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| BG004 | MEDI2338 300 MG | MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| BG005 | MEDI2338 1000 MG | MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | MEDI2338 100 MG | MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| OG003 | MEDI2338 300 MG | MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| OG004 | MEDI2338 1000 MG | MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| OG005 | Placebo | Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
|
|
| Primary | Incidence of Serious Adverse Events | Number of participants experiencing serious adverse events | All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis | Posted | Number | Participants | Days 1 - 92 |
|
|
|
| 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. | All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis | Posted | Number | Participants | Days 1 - 92 |
|
|
|
| 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. | All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis | Posted | Number | Participants | Days 1 - 92 |
|
|
|
| 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. | All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis | Posted | Number | Participants | Days 1 - 92 |
|
|
|
| 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. | All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis | Posted | Number | Participants | Days 1 - 92 |
|
|
|
| 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 | Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis | Posted | Mean | Standard Deviation | ng x day/mL | 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) |
|
|
|
| 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 | Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis | Posted | Mean | Standard Deviation | ng x day/mL | 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) |
|
|
|
| Secondary | Incidence of Anti-drug Antibodies (ADA) to MEDI2338 | Number of participants with ADA to MEDI2338 | Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the analysis of ADA | Posted | Number | Participants | Days 1, 57, and 92 |
|
|
|
| Secondary | Observed Maximum Concentration (Cmax) | Cmax of MEDI2338 | Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis | Posted | Mean | Standard Deviation | ng/mL | 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) |
|
|
|
| Secondary | Apparent Terminal Elimination Phase Half-life (t1/2) | t1/2 of MEDI2338 | Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis | Posted | Mean | Standard Deviation | Days | 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) |
|
|
|
| Secondary | Clearance (CL) | CL of MEDI2338 | Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis | Posted | Mean | Standard Deviation | L/Days | 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) |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | MEDI2338 10 MG | 0 | 3 | 3 | 3 |
| EG002 | MEDI2338 30 MG | 0 | 3 | 3 | 3 |
| EG003 | MEDI2338 100 MG | 0 | 6 | 6 | 6 |
| EG004 | MEDI2338 300 MG | 0 | 7 | 7 | 7 |
| EG005 | MEDI2338 1000 MG | 0 | 6 | 5 | 6 |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |