Chronic Obstructive Pulmonary DiseasePhase 1NCT01322594
A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
A Phase 1 study testing MEDI2338 in people with Chronic Obstructive Pulmonary Disease, run by MedImmune LLC at 4 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- MEDI2338
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
South Africa3 sites
Research Site
Bloemfontein, 9300
Research Site
George, 6529
Research Site
Port Elizabeth, 6045
About this study
Official title: A Phase 1, Single Ascending Dose Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
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
- Being tested
- MEDI2338, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI2338Biological
MEDI2338 single intravenous (IV) dose (lowest dose)
MEDI2338Biological
MEDI2338 single IV dose (next highest dose)
MEDI2338Biological
MEDI2338 single IV dose (next highest dose)
MEDI2338Biological
MEDI2338 single IV dose (next highest dose)
MEDI2338Biological
MEDI2338 single IV dose (highest dose)
PlaceboOther
Placebo single IV dose
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: MEDI2338 |
| Placebo | Placebo comparator | Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Measured: Days 1 - 92
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 1 - 92
Secondary outcomes (6)
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
Measured: 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
Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338
Measured: 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
Measured: Days 1, 57, and 92
Observed Maximum Concentration (Cmax)
Cmax of MEDI2338
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Piper, MBBS, Study director, MedImmune Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322594
- Sponsor's protocol ID
- CD-RI-MEDI2338-1033
- Other IDs
- 2010-022879-54
- Status last verified
- Oct 2013
- First submitted
- 23 Mar 2011
- Last updated
- 23 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Ascending Dose Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01322594
- Acronym / sponsor ID
- CD-RI-MEDI2338-1033
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Posted 23 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MEDI2338 10 MG | Experimental | Biological: MEDI2338MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump |
| MEDI2338 30 MG | Experimental | Biological: MEDI2338MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| MEDI2338 100 MG | Experimental | Biological: MEDI2338MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| MEDI2338 300 MG | Experimental | Biological: MEDI2338MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| MEDI2338 1000 MG | Experimental | Biological: MEDI2338MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
| Placebo | Placebo comparator | Other: PlaceboPlacebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI2338MEDI2338 single intravenous (IV) dose (lowest dose) | Biological | MEDI2338 10 MG |
| MEDI2338MEDI2338 single IV dose (next highest dose) | Biological | MEDI2338 30 MG |
| MEDI2338MEDI2338 single IV dose (next highest dose) | Biological | MEDI2338 100 MG |
| MEDI2338MEDI2338 single IV dose (next highest dose) | Biological | MEDI2338 300 MG |
| MEDI2338MEDI2338 single IV dose (highest dose) | Biological | MEDI2338 1000 MG |
| PlaceboPlacebo single IV dose | Other | Placebo |
Primary outcome
Incidence of Adverse Events
Time frame: Days 1 - 92
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Incidence of Serious Adverse Events
Time frame: Days 1 - 92
Number of participants experiencing serious adverse events
Incidence of Clinically Significant Hematology Laboratory Results
Time frame: Days 1 - 92
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.
Incidence of Clinically Significant Electrocardiogram Results
Time frame: Days 1 - 92
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.
Incidence of Clinically Significant Vital Signs Results
Time frame: Days 1 - 92
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.
Incidence of Clinically Significant Serum Chemistry Laboratory Results
Time frame: Days 1 - 92
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.
6 secondary outcomes
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity
Time frame: 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
Time frame: 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
Time frame: Days 1, 57, and 92
Observed Maximum Concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Piper, MBBS study director
MedImmune Ltd
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI2338 in people with Chronic Obstructive Pulmonary Disease, run by MedImmune LLC at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: Days 1 - 92). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2013.