AsthmaPhase 1NCT00512486
A Sequential Dose-Escalation Study in Subjects With Mild Asthma
A Phase 1 study testing MEDI-563 in people with Asthma, run by MedImmune LLC at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- MEDI-563
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2006to Oct 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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).
Who cannot join
- 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.
- 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.
- Any subject who has smoked cigarettes or cigars within one year prior to Visit 2 or has smoked for > 5 pack/years.
- Any subject with documented evidence of Hepatitis B virus, HIV or hepatitis C virus (HCV) infection.
- Any subject who has been documented as being Mantoux (PPD) positive.
- Any subject having a parasitic infection at any time in the past or intending to travel to an area where parasitic infections are endemic.
Show all 19Show fewer
- Any subject with any condition resulting in an increased eosinophil count (except asthma) at screening.
- Any subject with a Body Mass Index less than 15 kg/m2 or greater than 30 kg/m2 at Visit 1.
- Any subject with a documented history of disorders of the immune system (except asthma) at any time.
- Any subject with a clinically relevant abnormality of any laboratory parameter during the screening period (except eosinophilia due to asthma).
- 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.
- Any subject with a history of dependence on alcohol or drugs of abuse or with a positive drug screen at Visit 1.
- Any subject with known sensitivity to any constituent of BIW-8405/MEDI-563 or any other IL-5 receptor antagonist.
- 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.
- Any subject with a clinically significant relevant deviation from normal in physical examination, electrocardiography, or clinical laboratory tests, as determined by the Principal Investigator.
- 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.
- 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.
- Pregnant females will be excluded from study participation.
- Any subject who plans to undergo elective surgery within 4 weeks before Visit 2 (Day 0) through the end of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Jewish Medical and Research Center
Denver, Colorado, 80206
Allergy-Asthma-K4
Madison, Wisconsin, 53792
Northeast Medical Research Associates, Inc.
North Darthmouth, Massachusetts, 02747
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- MEDI-563
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-563Biological
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MEDI-563 Receives: Biological: MEDI-563 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the overall incidence of adverse events reported in each dose group.
Measured: Day 84
Secondary outcomes (3)
Laboratory assessments of safety (hematology, biochemistry and urinalysis), assessments of immunogenicity, vital signs, physical examinations, and ECGs.
Measured: Day 84
Safety will also be assessed by measurement of T-cell, B-cell, and NK counts using fluorescence activated cell sorter (FACS) technology.
Measured: Day 84
Secondary pharmacological endpoints will include assessments of eosinophil counts in peripheral blood, FENO, and ECP.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startNov 2006
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nestor Molfino, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512486
- Sponsor's protocol ID
- MI-CP158
- Status last verified
- Nov 2008
- First submitted
- 6 Aug 2007
- Last updated
- 27 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Single Administration, Sequential Dose Escalation of BIW-8405/MEDI-563 in Subjects With Mild Asthma
- ClinicalTrials.gov ID
- NCT00512486
- Acronym / sponsor ID
- MI-CP158
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: MEDI-563MEDI-563 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
- 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).
Key exclusion criteria (19 listed)
- 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.
- 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.
- Any subject who has smoked cigarettes or cigars within one year prior to Visit 2 or has smoked for > 5 pack/years.
- Any subject with documented evidence of Hepatitis B virus, HIV or hepatitis C virus (HCV) infection.
- Any subject who has been documented as being Mantoux (PPD) positive.
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 |
|---|---|---|
| MEDI-563BIW-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 | Biological | 1 |
Primary outcome
The primary endpoint will be the overall incidence of adverse events reported in each dose group.
Time frame: Day 84
3 secondary outcomes
Laboratory assessments of safety (hematology, biochemistry and urinalysis), assessments of immunogenicity, vital signs, physical examinations, and ECGs.
Time frame: 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
Secondary pharmacological endpoints will include assessments of eosinophil counts in peripheral blood, FENO, and ECP.
Time frame: Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2008.
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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.
Nestor Molfino, M.D. study director
MedImmune LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI-563 in people with Asthma, run by MedImmune LLC at 3 sites in United States.
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 4 inclusion and 19 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 27 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint will be the overall incidence of adverse events reported in each dose group. (time frame: Day 84). 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 27 Nov 2008; AzTrials last refreshed its copy on 1 Nov 2026.