Phase 1
N=31
A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT01322594 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Incidence of Adverse Events — 3; 3; 6; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MEDI2338 (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
3; 3; 6; 7; 5; 6 | — |
| PRIMARY Incidence of Serious Adverse Events |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Incidence of Clinically Significant Hematology Laboratory Results |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Incidence of Clinically Significant Electrocardiogram Results |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Incidence of Clinically Significant Vital Signs Results |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Incidence of Clinically Significant Serum Chemistry Laboratory Results |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve From Time Zero to Infinity |
27550.5; 104751.1; 281781.5; 915668.6; 3081728.5 | — |
| SECONDARY Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point |
24427.8; 87549.7; 250155.6; 846433.3; 2909818.8 | — |
| SECONDARY Incidence of Anti-drug Antibodies (ADA) to MEDI2338 |
0; 0; 0; 0; 0 | — |
| SECONDARY Observed Maximum Concentration (Cmax) |
2458.0; 9722.2; 27122.6; 106042.5; 337004.5 | — |
| SECONDARY Apparent Terminal Elimination Phase Half-life (t1/2) |
34.85; 40.85; 28.46; 26.76; 24.87 | — |
| SECONDARY Clearance (CL) |
0.387; 0.312; 0.365; 0.360; 0.346 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01322594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.