A Sequential Dose-Escalation Study in Subjects With Mild Asthma

November 26, 2008 updated by: MedImmune LLC

A Multi-Center, Open-Label, Single Administration, Sequential Dose Escalation of BIW-8405/MEDI-563 in Subjects With Mild Asthma

The primary objective of this study is to investigate the safety of administration of this drug by increasing doses to male and female adult subjects with mild asthma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective of this study is to investigate the safety of administration of BIW-8405/MEDI-563 in increasing doses to male and female adult subjects with mild asthma.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • Jewish Medical and Research Center
    • Massachusetts
      • North Darthmouth, Massachusetts, United States, 02747
        • Northeast Medical Research Associates, Inc.
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Allergy-Asthma-K4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female subjects aged 18 through 45 years in good general health other than asthma that is consistent with the definition of mild (intermittent or persistent) asthma by the 2002 Expert Panel report of the NAEPP: Night time symptoms no more than once weekly and day time symptoms <1 per day; lung function, FEV1 or PEF ≥ 80% of predicted value and PEF variability ≤ 30%. Note: the Principal Investigator must determine that the subject's asthma is consistent with this definition e.g., it is not required for the Investigator to obtain historical PEF values to calculate variability.
  2. Subjects with a PC20 methacholine of ≤ 8 mg/mL at Visit 1 (required for subjects in Cohorts 5-7) or documented within 6 months prior to Visit 1 (for subjects in Cohorts 1-4).3. Subjects who have provided written informed consent. Written informed consent must be obtained prior to performing any study related procedures.

4. Subjects who are considered by the Principal Investigator to be otherwise healthy, as judged by the absence of clinically significant diseases or clinically significant abnormal laboratory values that would confound interpretation of the study.

5. Women must be post menopausal, surgically sterile or willing to use birth control for the duration of the study. Birth control may include double barrier methods (e.g., condom with spermicide, hormonal contraceptives (provided they have been used regularly for at least 3 menstrual cycles) or IUD (provided it has remained in situ for at least three menstrual cycles).

Exclusion Criteria:

  1. All asthmatic subjects who have received topical steroids (except nonprescription topical steroids for dermatologic conditions) within 6 months prior to Visit 1 will be excluded.
  2. Any subject requiring a prescription medication, other than contraceptives or a β2 agonist (eg, albuterol) or anticholinergic agent (eg, ipratropium) for the treatment of mild asthma during the study. Subjects taking nonprescription medications must be willing and able to refrain from their use during the inpatient period of the study.
  3. Any subject who has smoked cigarettes or cigars within one year prior to Visit 2 or has smoked for > 5 pack/years.
  4. Any subject with documented evidence of Hepatitis B virus, HIV or hepatitis C virus (HCV) infection.
  5. Any subject who has been documented as being Mantoux (PPD) positive.
  6. Any subject having a parasitic infection at any time in the past or intending to travel to an area where parasitic infections are endemic.
  7. Any subject with any condition resulting in an increased eosinophil count (except asthma) at screening.
  8. Any subject with a Body Mass Index less than 15 kg/m2 or greater than 30 kg/m2 at Visit 1.
  9. Any subject with a documented history of disorders of the immune system (except asthma) at any time.
  10. Any subject with a clinically relevant abnormality of any laboratory parameter during the screening period (except eosinophilia due to asthma).
  11. Any subject who has participated in any other study of an investigational product within either 30 days or 10 half lives (if known) prior to Visit 2, whichever is longer.
  12. Any subject with a history of dependence on alcohol or drugs of abuse or with a positive drug screen at Visit 1.
  13. Any subject with known sensitivity to any constituent of BIW-8405/MEDI-563 or any other IL-5 receptor antagonist.
  14. Any subject with a history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorder that is capable of altering the metabolism or elimination of drugs or that constitutes a risk factor when taking the study medication.
  15. Any subject with a clinically significant relevant deviation from normal in physical examination, electrocardiography, or clinical laboratory tests, as determined by the Principal Investigator.
  16. Any subject who has donated blood or in any other way had a loss of blood volume greater than 450 mL within 30 days before beginning the study injection.
  17. Any subject who is unwilling to reside in the clinic during the study period or is unwilling to cooperate fully with the Principal Investigator or designee.
  18. Pregnant females will be excluded from study participation.
  19. Any subject who plans to undergo elective surgery within 4 weeks before Visit 2 (Day 0) through the end of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1
MEDI-563
Biological: MEDI-563

BIW-8405/MEDI-563 administered at one of five dose levels:

  • 0.03 mg/kg intravenous injection
  • 0.1 mg/kg intravenous injection
  • 0.3 mg/kg intravenous injection
  • 1.0 mg/kg intravenous injection
  • 3.0 mg/kg intravenous injection

Following the -3.0 mg/kg dose level,

BIW-8405/MEDI-563 administered at one of two lower dose levels:

0.003 mg/kg intravenous injection 0.0003 mg/kg intravenous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary endpoint will be the overall incidence of adverse events reported in each dose group.
Time Frame: Day 84
Day 84

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Laboratory assessments of safety (hematology, biochemistry and urinalysis), assessments of immunogenicity, vital signs, physical examinations, and ECGs.
Time Frame: Day 84
Day 84
Safety will also be assessed by measurement of T-cell, B-cell, and NK counts using fluorescence activated cell sorter (FACS) technology.
Time Frame: Day 84
Day 84
Secondary pharmacological endpoints will include assessments of eosinophil counts in peripheral blood, FENO, and ECP.
Time Frame: Day 84
Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedImmune LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nestor Molfino, M.D., MedImmune LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MI-CP158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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