AsthmaPhase 1NCT00192296
Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers
A Phase 1 study testing MEDI-528 0.3 mg/kg, MEDI-528 1 mg/kg and MEDI-528 3 mg/kg in people with Asthma, run by MedImmune LLC at 1 site in United States.
Trial summary
Phase I study to evaluate the safety and tolerability of escalating single IV doses of MEDI-528. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- MEDI-528 0.3 mg/kg, MEDI-528 1 mg/kg and MEDI-528 3 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Mar 2005
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females age 18 up to and including 49 years of age at the time of the first dose of study drug
- Weight < 89 kg
- Written informed consent obtained from the volunteer
- Healthy by medical history and physical examination
- Sexually active females, unless surgically sterile or at least one year post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap,abstinence, use of a condom by the sexual partner or sterile sexual partner) for 3 months before the first dose of study drug, and must agree to continue using such precautions through 84 days after their dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions through 84 days after their dose of study drug.
- Use of common over-the-counter medications such as topical corticosteroids, decongestants, antihistamines, analgesics, and antacids is permitted unless, in the opinion of the investigator, it would interfere with either the volunteer's ability to complete the study or interpretation of study results.
- Ability to complete the follow-up period of 84 days
- Willing to forego other forms of experimental treatment during the study period of 84 days
Who cannot join
- Acute illnesses or evidence of significant active infection, such as fever ≥38.0°C (100.5°F) at the start of the study
- Use of prescription medications, other than contraceptives, in the 28-day period before Study Day 0
- Blood donation in excess of 400 mL within 6 months of the time of entry into the study
- History of use of tobacco products within 3 years of Study Day 0 or history of smoking of >10 pack-years
- History of immunodeficiency or receipt or current use of immunosuppressive drugs including systemic corticosteroids
- History of allergic disease or reactions likely to be exacerbated by any component of the Study Drug (described in the Investigator's Brochure)
Show all 17Show fewer
- History of substance abuse that, in the opinion of the investigator, may compromise the ability of the study subject to complete the study and follow-up period
- Evidence of any systemic disease on physical examination
- Evidence of infection with hepatitis A, B, or C virus or HIV-1
- Receipt of immunoglobulins or blood products within 60 days of entering the study
- Receipt of any investigational drug therapy within 60 days of the first dose of study drug through Study Day 84 (use of licensed agents for indications not listed in the package insert is permitted)
- Any of the following: CBC: Hgb < 12.0 gm/dL; WBC < 4,000/mm3; platelet count <125,000/mm3 (or laboratory normal values); Na, K, Cl, CO2, AST, ALT, BUN, 4-hour fasting glucose, amylase, lipase, creatinine, troponin > upper limit of normal; other abnormal laboratory values in the screening panel which in the opinion of the principal investigator are judged to be clinically significant.
- Clinically significant abnormality, as determined by the investigator, on 12-lead electrocardiogram at the time of initial screening
- Elective surgery planned during the study period through Study Day 84
- Pregnancy (sexually active females must have a negative serum pregnancy test on the day of the first dose of the study drug, before dosing)
- Nursing mother
- The presence of any acute or chronic organ-specific condition or any concern, which in the opinion of the investigator, may interfere with the conduct or interpretation of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528, a Humanized Monoclonal Anti-Interleukin-9 Antibody, in Healthy Adult Volunteers
Phase I study to evaluate the safety and tolerability of escalating single IV doses of MEDI-528.
Read the detailed description
The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single IV doses of MEDI-528 administered to healthy adult volunteers.
- Conditions
- Asthma
- Being tested
- MEDI-528 0.3 mg/kg, MEDI-528 1 mg/kg, MEDI-528 3 mg/kg, MEDI-528 9 mg/kg
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-528 0.3 mg/kgBiological
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kgBiological
MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kgBiological
MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kgBiological
MEDI-528 (9 mg/kg) administered as a single, IV dose
| Study group | Role | What they receive |
|---|---|---|
| MEDI-528 0.3 mg/kg | Experimental | MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose Receives: Biological: MEDI-528 0.3 mg/kg |
| MEDI-528 1 mg/kg | Experimental | MEDI-528 (1 mg/kg) administered as a single, IV dose Receives: Biological: MEDI-528 1 mg/kg |
| MEDI-528 3 mg/kg | Experimental | MEDI-528 (3 mg/kg) administered as a single, IV dose Receives: Biological: MEDI-528 3 mg/kg |
| MEDI-528 9 mg/kg | Experimental | MEDI-528 (9 mg/kg) administered as a single, IV dose Receives: Biological: MEDI-528 9 mg/kg |
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 0 - 84
Incidence of Abnormal Troponin Levels
Number of participants with troponin levels greater than upper limit of normal (> 0.05 ng/mL)
Measured: Days 0, 7, 14, 21, and 28
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events
Measured: Days 0 - 84
Secondary outcomes (9)
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Number of participants who had ADA detected at each time point
Measured: Days 14, 28, 42, and 84
Time to Observed Maximum Serum Concentration (Tmax)
Tmax of MEDI-528
Measured: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Observed Maximum Serum Concentration (Cmax)
Cmax of MEDI-528
Measured: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
AUC(0-t) of MEDI-528
Measured: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
AUC(0-infinity) of MEDI-528
Measured: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
AUC(ext) of MEDI-528
Measured: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Total Body Clearance (CL)
CL of MEDI-528
Measured: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Half-life (T1/2)
T1/2 of MEDI-528
Measured: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Terminal Phase Elimination Rate (Vz)
Vz of MEDI-528
Measured: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionFeb 2005
- Study completionMar 2005
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramon Vargas, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192296
- Sponsor's protocol ID
- MI-CP105
- Status last verified
- Feb 2014
- First submitted
- 12 Sep 2005
- Last updated
- 6 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
White B, Leon F, White W, Robbie G. Two first-in-human, open-label, phase I dose-escalation safety trials of MEDI-528, a monoclonal antibody against interleukin-9, in healthy adult volunteers. Clin Ther. 2009 Apr;31(4):728-40. doi: 10.1016/j.clinthera.2009.04.019.
PubMed 19446146
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528, a Humanized Monoclonal Anti-Interleukin-9 Antibody, in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00192296
- Acronym / sponsor ID
- MI-CP105
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Feb 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 6 Mar 2014
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 escalating single IV doses of MEDI-528.
Detailed description
The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single IV doses of MEDI-528 administered to healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MEDI-528 0.3 mg/kg | Experimental | Biological: MEDI-528 0.3 mg/kgMEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose |
| MEDI-528 1 mg/kg | Experimental | Biological: MEDI-528 1 mg/kgMEDI-528 (1 mg/kg) administered as a single, IV dose |
| MEDI-528 3 mg/kg | Experimental | Biological: MEDI-528 3 mg/kgMEDI-528 (3 mg/kg) administered as a single, IV dose |
| MEDI-528 9 mg/kg | Experimental | Biological: MEDI-528 9 mg/kgMEDI-528 (9 mg/kg) administered as a single, IV dose |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males and females age 18 up to and including 49 years of age at the time of the first dose of study drug
- Weight < 89 kg
- Written informed consent obtained from the volunteer
- Healthy by medical history and physical examination
- Sexually active females, unless surgically sterile or at least one year post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap,abstinence, use of a condom by the sexual partner or sterile sexual partner) for 3 months before the first dose of study drug, and must agree to continue using such precautions through 84 days after their dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions through 84 days after their dose of study drug.
Key exclusion criteria (17 listed)
- Acute illnesses or evidence of significant active infection, such as fever ≥38.0°C (100.5°F) at the start of the study
- Use of prescription medications, other than contraceptives, in the 28-day period before Study Day 0
- Blood donation in excess of 400 mL within 6 months of the time of entry into the study
- History of use of tobacco products within 3 years of Study Day 0 or history of smoking of >10 pack-years
- History of immunodeficiency or receipt or current use of immunosuppressive drugs including systemic corticosteroids
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-528 0.3 mg/kgMEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose | Biological | MEDI-528 0.3 mg/kg |
| MEDI-528 1 mg/kgMEDI-528 (1 mg/kg) administered as a single, IV dose | Biological | MEDI-528 1 mg/kg |
| MEDI-528 3 mg/kgMEDI-528 (3 mg/kg) administered as a single, IV dose | Biological | MEDI-528 3 mg/kg |
| MEDI-528 9 mg/kgMEDI-528 (9 mg/kg) administered as a single, IV dose | Biological | MEDI-528 9 mg/kg |
Primary outcome
Incidence of Adverse Events
Time frame: Days 0 - 84
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Incidence of Abnormal Troponin Levels
Time frame: Days 0, 7, 14, 21, and 28
Number of participants with troponin levels greater than upper limit of normal (> 0.05 ng/mL)
Incidence of Serious Adverse Events
Time frame: Days 0 - 84
Number of participants experiencing serious adverse events
9 secondary outcomes
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Time frame: Days 14, 28, 42, and 84
Time to Observed Maximum Serum Concentration (Tmax)
Time frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Observed Maximum Serum Concentration (Cmax)
Time frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
Time frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
Time frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
Time frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Total Body Clearance (CL)
Time frame: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Half-life (T1/2)
Time frame: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Terminal Phase Elimination Rate (Vz)
Time frame: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19446146White B, Leon F, White W, Robbie G. Two first-in-human, open-label, phase I dose-escalation safety trials of MEDI-528, a monoclonal antibody against interleukin-9, in healthy adult volunteers. Clin Ther. 2009 Apr;31(4):728-40. doi: 10.1016/j.clinthera.2009.04.019.
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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.
Ramon Vargas, MD principal investigator
1 site 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-528 0.3 mg/kg, MEDI-528 1 mg/kg and MEDI-528 3 mg/kg in people with Asthma, run by MedImmune LLC at 1 site 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 8 inclusion and 17 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 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 6 Mar 2014). 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 0 - 84). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00192296, which also lists 1 linked publication.
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 6 Mar 2014.