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CompletedNCT00394654Updated Dec 11, 2013Results posted

A Study to Evaluate the Efficacy of MEDI-528 on Late Asthmatic Response With Atopic Asthma

A Phase 2 interventional study of MEDI-528 9 mg/kg and Placebo in Asthma, sponsored by MedImmune LLC. Completed at 3 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-12-11.

Sponsored by MedImmune LLC (part of AstraZeneca) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma.

Read the detailed description

This study (MI-CP138) is a Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma. Approximately three investigative sites in Canada will participate in this study, with up to 40 evaluable patients randomized in a 1:1 ratio to receive MEDI-528 (9.0 mg/kg) or placebo as a single IV infusion.

02

Conditions studied

  • Asthma

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03

In context

Asthma

4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 30 is below the median of 83 across 2,814 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

MedImmune LLC is the lead sponsor of 270 studies on the registry; none are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 29 (56%) have results posted.

First submitted before MedImmune LLC became part of AstraZeneca.

Browse MedImmune LLC studies →All AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female adults, age 18 through 65 years of age at the time of screening;
  • Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
  • Previously documented diagnosis of asthma of > 1 year duration, based on episodic symptoms of airflow obstruction, at least partial reversibility of airflow obstruction, with alternative diagnoses (e.g., chronic obstructive pulmonary disease) ruled out;
  • AHR in the methacholine challenge test with a PC20 (provoking concentration of methacholine to cause a 20% fall in FEV1) ≤ 16 mg/mL (Crapo, 2000);
  • Have dual response of EAR, defined as a decrease in FEV1 ≥ 20% at 0 to 3 hours after inhalation, and LAR, defined as a decrease in FEV1 ≥ 15% 3 to 7 hours after inhalation, to inhaled allergen;
  • Asthma symptoms are adequately controlled on short-acting β2 agonists (e.g., albuterol) alone;
  • Have had no significant changes in regular asthma medications and no acute asthma exacerbations requiring corticosteroid rescue, hospitalization, or emergency department visits for at least 4 weeks prior to screening and up through the time of the first dose of study drug on Study Day 0.
  • Sexually active women, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug on Study Day 0, and must agree to continue using such precautions through Study Day 126. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active men, unless surgically sterile, must likewise use an effective method of birth control (condom) and must agree to continue using such precautions through Study Day 126;
  • Able to complete the follow-up period through Study Day 126, as required by the protocol.
  • Willing to forego other forms of experimental treatment and study procedures during the study; and
  • Able to provide spirometric readings that meet American Thoracic Society (ATS) standards (ATS, 1995).

Exclusion criteria

Exclusion Criteria:

  • Receipt of MEDI-528 in any previous clinical study;
  • History of allergy or adverse reactions to any component of the MEDI-528 formulation;
  • Lung disease other than allergic asthma (e.g. chronic bronchitis);
  • Current use of any systemic or inhaled immunosuppressive drugs, including systemic and inhaled corticosteroids (topical corticosteroids are permitted), long-acting β2 agonists, leukotriene antagonists, cromolyn sodium, nedocromil sodium, theophylline or any inhaled or systemic medication for asthma other than short-acting β2 agonists, for at least 4 weeks prior to study drug administration on Study Day 0.
  • Current use of any β-adrenergic antagonist (e.g. propranolol).
  • Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period.
  • Acute illnesses or evidence of clinically significant active infection, such as fever ³ 38.0°C (100.5°F) at screening and through the time of the study drug administration on Study Day 0;
  • Current allergy-vaccination therapy (i.e., desensitization immunotherapy) with less than 3 months of stable maintenance doses prior to the baseline allergen inhalation challenge;
  • Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to the first dose of study drug through Study Day 150;
  • Receipt of any therapy with a leukocyte-depleting agent unless recovery in white cell count has been documented before screening;
  • Pregnancy (sexually active females must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
  • Is a nursing mother at the time of study enrollment;
  • Evidence of infection with hepatitis B or C virus, or HIV-1 or HIV-2, or active infection with hepatitis A;
  • History of significant systemic disease (e.g., cancer; infection; coronary artery disease or other cardiovascular disease; or hematological, renal, hepatic, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease);
  • History of cancer other than nonmelanoma skin cancer or cervical carcinoma-in-situ that have been treated successfully with curative therapy;
  • History of primary immunodeficiency;
  • History of pancreatitis;
  • History of use of tobacco products within 2 years of baseline or history of smoking >= 10 pack-years;
  • Elective surgery planned from the time of screening through Study Day 126;
  • Clinically significant abnormalities (other than asthma) upon physical examination prior to study drug administration on Study Day 0;
  • Clinically significant abnormality, as determined by the investigator, on 12-lead ECG or chest radiograph at the time of screening;
  • At the time of screening, any of the following abnormalities: aspartate transaminase (AST), alanine transaminase (ALT), or amylase > 1.5 × above the upper limits of normal (ULN); or serum creatinine > 1.3 × ULN; or any other abnormal laboratory values in the screening panel that, in the opinion of the principal investigator (PI), are judged to be clinically significant; or
  • Evidence of any systemic disease or respiratory disease (other than asthma), any finding upon physical examination or history of any disease that, in the opinion of the PI or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    MEDI528 9 mg/kg

    MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion

    Biological: MEDI-528 9 mg/kg

  • Placebo comparator
    PLACEBO

    Placebo administered as a single intravenous infusion

    Other: Placebo

Interventions

  • BiologicalMEDI-528 9 mg/kg

    Drug page: Enokizumab

    MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion

  • OtherPlacebo

    Placebo administered as a single intravenous infusion

06

What researchers measure

Primary outcomes

  1. Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7

    Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.

    Time frame: Day 7

  2. Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28

    Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

    Time frame: Day 28

  3. Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56

    Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

    Time frame: Day 56

  4. Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7

    Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

    Time frame: Day 7

  5. Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28

    Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

    Time frame: Day 28

  6. Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56

    Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

    Time frame: Day 56

Secondary outcomes

  1. Incidence of Adverse Events

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

    Time frame: Days 0 - 126

  2. Incidence of Serious Adverse Events

    Number of participants experiencing serious adverse events

    Time frame: Days 0 - 126

  3. Incidence of Anti-drug Antibodies (ADA) to MEDI-528

    Number of participants with ADA to MEDI-528

    Time frame: Days 0, 27, 55, 84, and 126

  4. Time to Observed Maximum Serum Concentration (Tmax)

    Tmax of MEDI-528 in serum

    Time frame: Days 0, 6, 7, 27, 55, 84, and 126

  5. Time to Observed Maximum Sputum Concentration (Tmax)

    Tmax of MEDI-528 in sputum

    Time frame: Days -21 to -7, 7, 28, and 56

  6. Time to Observed Maximum Nasal Lavage Concentration (Tmax)

    Tmax of MEDI-528 in nasal lavage

    Time frame: Days -6 to -1, 8, 29, and 57

  7. Observed Maximum Serum Concentration (Cmax)

    Cmax of MEDI-528 in serum

    Time frame: Days 0, 6, 7, 27, 55, 84, and 126

  8. Observed Maximum Sputum Concentration (Cmax)

    Cmax of MEDI-528 in sputum

    Time frame: Days -21 to -7, 7, 28, and 56

  9. Observed Maximum Nasal Lavage Concentration (Cmax)

    Cmax of MEDI-528 in nasal lavage

    Time frame: Days -6 to -1, 8, 29, and 57

  10. Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]

    AUC(0-t) of MEDI-528 in serum

    Time frame: Days 0, 6, 7, 27, 55, 84, and 126

  11. Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]

    AUC(0-t) of MEDI-528 in sputum

    Time frame: Days -21 to -7, 7, 28, and 56

  12. Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]

    AUC(0-t) of MEDI-528 in nasal lavage

    Time frame: Days -6 to -1, 8, 29, and 57

  13. Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]

    AUC(0-infinity) of MEDI-528 in serum

    Time frame: Days 0, 6, 7, 27, 55, 84, and 126

  14. Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]

    AUC(0-infinity) of MEDI-528 in sputum

    Time frame: Days -21 to -7, 7, 28, and 56

  15. Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]

    AUC(0-infinity) of MEDI-528 in nasal lavage

    Time frame: Days -6 to -1, 8, 29, and 57

  16. Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]

    AUC(ext) of MEDI-528 in serum

    Time frame: Days 0, 6, 7, 27, 55, 84, and 126

  17. Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]

    AUC(ext) of MEDI-528 in sputum

    Time frame: Days -21 to -7, 7, 28, and 56

  18. Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]

    AUC(ext) of MEDI-528 in nasal lavage

    Time frame: Days -6 to -1, 8, 29, and 57

  19. Terminal Phase Half-Life (T1/2)

    T1/2 of MEDI-528 in serum

    Time frame: Days 0, 6, 7, 27, 55, 84, and 126

  20. Terminal Phase Half-Life (T1/2)

    T1/2 of MEDI-528 in sputum

    Time frame: Days -21 to -7, 7, 28, and 56

  21. Terminal Phase Half-Life (T1/2)

    T1/2 of MEDI-528 in nasal lavage

    Time frame: Days -6 to -1, 8, 29, and 57

  22. Total Body Clearance (CL)

    CL of MEDI-528 in serum

    Time frame: Days 0, 6, 7, 27, 55, 84, and 126

  23. Terminal Phase Volume of Distribution (Vz)

    Vz of MEDI-528 in serum

    Time frame: Days 0, 6, 7, 27, 55, 84, and 126

07

Results

Posted Dec 11, 2013

Participant flow

Thirty patients were entered into the study between 16Oct2006 and 15Aug2007 at 2 sites in Canada.

Participant flow — Overall Study
MilestonePLACEBOMEDI528 9 mg/kg
Started1515
Completed1315
Not completed20
Withdrew: Lost to follow-up10
Withdrew: Participant left stduy region10

Outcome measures

PrimaryEffect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7

Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.

Time frame:
Day 7
Reported as:
Mean · Percent
Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7
PercentPLACEBOMEDI528 9 mg/kg
Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 721.26 ± 69.288-16.21 ± 61.788
Statistical analysis
  • PLACEBO vs MEDI528 9 mg/kg · Univariate 2-sample t-test · p = 0.168
PrimaryEffect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28

Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

Time frame:
Day 28
Reported as:
Mean · Percent
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28
PercentPLACEBOMEDI528 9 mg/kg
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 2829.93 ± 46.646-16.95 ± 123.256
Statistical analysis
  • PLACEBO vs MEDI528 9 mg/kg · Univariate 2-sample t-test · p = 0.254
PrimaryEffect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56

Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

Time frame:
Day 56
Reported as:
Mean · Percent
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56
PercentPLACEBOMEDI528 9 mg/kg
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 5640.36 ± 45.12331.85 ± 53.709
Statistical analysis
  • PLACEBO vs MEDI528 9 mg/kg · Univariate 2-sample t-test · p = 0.677
PrimaryEffect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7

Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

Time frame:
Day 7
Reported as:
Mean · Percent
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7
PercentPLACEBOMEDI528 9 mg/kg
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 721.86 ± 94.34-14.47 ± 82.43
Statistical analysis
  • PLACEBO vs MEDI528 9 mg/kg · Univariate 2-sample t-test · p = 0.318
PrimaryEffect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28

Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

Time frame:
Day 28
Reported as:
Mean · Percent
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28
PercentPLACEBOMEDI528 9 mg/kg
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 282.91 ± 133.75-13.09 ± 175.27
Statistical analysis
  • PLACEBO vs MEDI528 9 mg/kg · Univariate 2-sample t-test · p = 0.798
PrimaryEffect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56

Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.

Time frame:
Day 56
Reported as:
Mean · Percent
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56
PercentPLACEBOMEDI528 9 mg/kg
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 5641.75 ± 65.4951.91 ± 98.49
Statistical analysis
  • PLACEBO vs MEDI528 9 mg/kg · Univariate 2-sample t-test · p = 0.766
SecondaryIncidence of Adverse Events

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

Time frame:
Days 0 - 126
Reported as:
Number · Participants
Incidence of Adverse Events
ParticipantsPLACEBOMEDI528 9 mg/kg
Incidence of Adverse Events1112
SecondaryIncidence of Serious Adverse Events

Number of participants experiencing serious adverse events

Time frame:
Days 0 - 126
Reported as:
Number · Participants
Incidence of Serious Adverse Events
ParticipantsPLACEBOMEDI528 9 mg/kg
Incidence of Serious Adverse Events10
SecondaryIncidence of Anti-drug Antibodies (ADA) to MEDI-528

Number of participants with ADA to MEDI-528

Time frame:
Days 0, 27, 55, 84, and 126
Reported as:
Number · Participants
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
ParticipantsPLACEBOMEDI528 9 mg/kg
Incidence of Anti-drug Antibodies (ADA) to MEDI-52800
SecondaryTime to Observed Maximum Serum Concentration (Tmax)

Tmax of MEDI-528 in serum

Time frame:
Days 0, 6, 7, 27, 55, 84, and 126
Reported as:
Geometric mean · Day
Time to Observed Maximum Serum Concentration (Tmax)
DayPLACEBOMEDI528 9 mg/kg
Time to Observed Maximum Serum Concentration (Tmax)—0.028 ± 20.4
SecondaryTime to Observed Maximum Sputum Concentration (Tmax)

Tmax of MEDI-528 in sputum

Time frame:
Days -21 to -7, 7, 28, and 56
Reported as:
Geometric mean · Day
Time to Observed Maximum Sputum Concentration (Tmax)
DayPLACEBOMEDI528 9 mg/kg
Time to Observed Maximum Sputum Concentration (Tmax)—9.276 ± 99
SecondaryTime to Observed Maximum Nasal Lavage Concentration (Tmax)

Tmax of MEDI-528 in nasal lavage

Time frame:
Days -6 to -1, 8, 29, and 57
Reported as:
Geometric mean · Day
Time to Observed Maximum Nasal Lavage Concentration (Tmax)
DayPLACEBOMEDI528 9 mg/kg
Time to Observed Maximum Nasal Lavage Concentration (Tmax)—10.319 ± 169.6
SecondaryObserved Maximum Serum Concentration (Cmax)

Cmax of MEDI-528 in serum

Time frame:
Days 0, 6, 7, 27, 55, 84, and 126
Reported as:
Geometric mean · Microgram per milliliter
Observed Maximum Serum Concentration (Cmax)
Microgram per milliliterPLACEBOMEDI528 9 mg/kg
Observed Maximum Serum Concentration (Cmax)—229.672 ± 18.1
SecondaryObserved Maximum Sputum Concentration (Cmax)

Cmax of MEDI-528 in sputum

Time frame:
Days -21 to -7, 7, 28, and 56
Reported as:
Geometric mean · Nanogram per milliliter
Observed Maximum Sputum Concentration (Cmax)
Nanogram per milliliterPLACEBOMEDI528 9 mg/kg
Observed Maximum Sputum Concentration (Cmax)—71.843 ± 78.7
SecondaryObserved Maximum Nasal Lavage Concentration (Cmax)

Cmax of MEDI-528 in nasal lavage

Time frame:
Days -6 to -1, 8, 29, and 57
Reported as:
Geometric mean · Nanogram per milliliter
Observed Maximum Nasal Lavage Concentration (Cmax)
Nanogram per milliliterPLACEBOMEDI528 9 mg/kg
Observed Maximum Nasal Lavage Concentration (Cmax)—79.406 ± 136.6
SecondaryArea Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]

AUC(0-t) of MEDI-528 in serum

Time frame:
Days 0, 6, 7, 27, 55, 84, and 126
Reported as:
Geometric mean · Microgram times day per milliliter
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
Microgram times day per milliliterPLACEBOMEDI528 9 mg/kg
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]—5744.821 ± 14.8
SecondaryArea Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]

AUC(0-t) of MEDI-528 in sputum

Time frame:
Days -21 to -7, 7, 28, and 56
Reported as:
Geometric mean · Nanogram times day per milliliter
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
Nanogram times day per milliliterPLACEBOMEDI528 9 mg/kg
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]—2382.123 ± 84
SecondaryArea Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]

AUC(0-t) of MEDI-528 in nasal lavage

Time frame:
Days -6 to -1, 8, 29, and 57
Reported as:
Geometric mean · Nanogram times day per milliliter
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
Nanogram times day per milliliterPLACEBOMEDI528 9 mg/kg
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]—1332.408 ± 147.6
SecondaryArea Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]

AUC(0-infinity) of MEDI-528 in serum

Time frame:
Days 0, 6, 7, 27, 55, 84, and 126
Reported as:
Geometric mean · Microgram times day per milliliter
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
Microgram times day per milliliterPLACEBOMEDI528 9 mg/kg
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]—6224.272 ± 17
SecondaryArea Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]

AUC(0-infinity) of MEDI-528 in sputum

Time frame:
Days -21 to -7, 7, 28, and 56
Reported as:
Geometric mean · Nanogram times day per milliliter
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
Nanogram times day per milliliterPLACEBOMEDI528 9 mg/kg
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]—4136.234 ± 61.9
SecondaryArea Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]

AUC(0-infinity) of MEDI-528 in nasal lavage

Time frame:
Days -6 to -1, 8, 29, and 57
Reported as:
Geometric mean · Nanogram times day per milliliter
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
Nanogram times day per milliliterPLACEBOMEDI528 9 mg/kg
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]—6047.098 ± 134
SecondaryPercent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]

AUC(ext) of MEDI-528 in serum

Time frame:
Days 0, 6, 7, 27, 55, 84, and 126
Reported as:
Geometric mean · Percent
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
PercentPLACEBOMEDI528 9 mg/kg
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]—6.441 ± 59.3
SecondaryPercent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]

AUC(ext) of MEDI-528 in sputum

Time frame:
Days -21 to -7, 7, 28, and 56
Reported as:
Geometric mean · Percent
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
PercentPLACEBOMEDI528 9 mg/kg
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]—25.919 ± 81.3
SecondaryPercent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]

AUC(ext) of MEDI-528 in nasal lavage

Time frame:
Days -6 to -1, 8, 29, and 57
Reported as:
Geometric mean · Percent
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
PercentPLACEBOMEDI528 9 mg/kg
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]—18.848 ± 178.3
SecondaryTerminal Phase Half-Life (T1/2)

T1/2 of MEDI-528 in serum

Time frame:
Days 0, 6, 7, 27, 55, 84, and 126
Reported as:
Geometric mean · Day
Terminal Phase Half-Life (T1/2)
DayPLACEBOMEDI528 9 mg/kg
Terminal Phase Half-Life (T1/2)—34.316 ± 20.8
SecondaryTerminal Phase Half-Life (T1/2)

T1/2 of MEDI-528 in sputum

Time frame:
Days -21 to -7, 7, 28, and 56
Reported as:
Geometric mean · Day
Terminal Phase Half-Life (T1/2)
DayPLACEBOMEDI528 9 mg/kg
Terminal Phase Half-Life (T1/2)—31.933 ± 83.1
SecondaryTerminal Phase Half-Life (T1/2)

T1/2 of MEDI-528 in nasal lavage

Time frame:
Days -6 to -1, 8, 29, and 57
Reported as:
Geometric mean · Day
Terminal Phase Half-Life (T1/2)
DayPLACEBOMEDI528 9 mg/kg
Terminal Phase Half-Life (T1/2)—25.584 ± 69
SecondaryTotal Body Clearance (CL)

CL of MEDI-528 in serum

Time frame:
Days 0, 6, 7, 27, 55, 84, and 126
Reported as:
Geometric mean · Liter per day
Total Body Clearance (CL)
Liter per dayPLACEBOMEDI528 9 mg/kg
Total Body Clearance (CL)—0.101 ± 26.7
SecondaryTerminal Phase Volume of Distribution (Vz)

Vz of MEDI-528 in serum

Time frame:
Days 0, 6, 7, 27, 55, 84, and 126
Reported as:
Geometric mean · Liter
Terminal Phase Volume of Distribution (Vz)
LiterPLACEBOMEDI528 9 mg/kg
Terminal Phase Volume of Distribution (Vz)—5.025 ± 23.8

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PLACEBO—1/15 (6.7%)11/15 (73.3%)
MEDI528 9 mg/kg—0/15 (0%)12/15 (80%)
Most frequent serious events
Most frequent serious events
EventPLACEBOMEDI528 9 mg/kg
EpilepsyNervous system disorders1/150/15
Most frequent other events
Showing 10 of 38
Most frequent other events
EventPLACEBOMEDI528 9 mg/kg
Blood potassium decreasedInvestigations4/154/15
Lymphocyte count decreasedInvestigations3/150/15
Protein urine presentInvestigations1/153/15
White blood cell count decreasedInvestigations3/151/15
NauseaGastrointestinal disorders0/152/15
AstheniaGeneral disorders0/152/15
NasopharyngitisInfections and infestations0/152/15
Neutrophil count decreasedInvestigations2/150/15
Back painMusculoskeletal and connective tissue disorders0/152/15
DizzinessNervous system disorders0/152/15

Baseline characteristics

Age Continuous
Age Continuous(Years)PLACEBOMEDI528 9 mg/kgTotal
Mean30.5 ± 9.626.5 ± 7.828.5 ± 8.9
Sex: Female, Male
Sex: Female, Male(Participants)PLACEBOMEDI528 9 mg/kgTotal
Female9918
Male6612
08

Study locations

3 sites
  • McMaster University
    Hamilton, Ontario L8N 3Z5, Canada
  • Hopital Laval
    Québec, Quebec G1V 4G5, Canada
  • University of Saskatchewan
    Saskatoon, Saskatchewan S7N 0W8, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00394654
Lead sponsor
MedImmune LLC
Responsible party
Sponsor
First posted
Nov 1, 2006
Start date
Nov 2006
Primary completion
Aug 2007
Completion
Jan 2008
Results posted
Dec 11, 2013
Last update
Dec 11, 2013

Study contacts

Nestor Molfino, M.D.
study director · MedImmune LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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