HealthyPhase 1NCT00116168
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528
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 Healthy, run by MedImmune LLC at 2 sites in United States.
Trial summary
A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2005to Jul 2006
- 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 19 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females age 19 up to, and including, 49 years of age at the time of the first dose of study drug
- Weight less than 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 two years post-menopausal or an FSH≥40 mIu/mL, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, 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 the study period of 84 days. 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 Study Day 84 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 the study results.
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- 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
- Willing to forego vigorous activity 1 - 2 days before dosing, and before each study visit.
Who cannot join
- Acute illnesses or evidence of significant active infection, such as fever greater than or equal to 38.0 C (100.5°F) at the start of the study
- Use of prescription medications, other than oral contraceptives, in the 28-day period before Study Day 0
- Any blood donation or significant loss of blood within 6 months of time of entry into the study
- History of immunodeficiency or receipt of immunosuppressive drugs
- History of allergy or reaction to any component of the MEDI-528 formulation
- 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
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- Evidence of any systemic disease, neurologic abnormality, lymphadenopathy, or splenomegaly upon 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 or standard vaccine therapy, other than vaccination for influenza, 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)
- Receipt of MEDI-528 in any previous clinical study
- At Screening (must be within 21 days before study dose administration) any of the following: Hgb, total WBC, platelet count, Na, K, C1, CO2, AST, ALT, BUN, glucose, amylase, lipase, creatinine, or troponin out of the normal range; other abnormal laboratory values in the screening panel that, 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
- Clinically significant abnormalities noted on baseline brain MRI
- 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 study drug, before dosing)
- Nursing mother
- The presence of any condition or concern which, in the opinion of the investigator, may interfere with the conduct or interpretation of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MDS Pharma Services
Lincoln, Nebraska, 68502
MDS Pharma Services
New Orleans, Louisiana, 70119
About this study
Official title: A Phase I, Open Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528, a Humanized Monoclonal Anti-Interleukin-9 Antibody, in Healthy Adult Volunteers
A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.
Read the detailed description
The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single SC doses of MEDI-528 administered to healthy adult volunteers in four dose groups.
- Conditions
- Healthy
- Being tested
- MEDI-528 0.3 mg/kg, MEDI-528 1 mg/kg, MEDI-528 3 mg/kg, MEDI-528 9 mg/kg
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, subcutaneous (SC) dose
MEDI-528 1 mg/kgBiological
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 3 mg/kgBiological
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 9 mg/kgBiological
MEDI-528 (9 mg/kg) administered as a single, SC dose
| Study group | Role | What they receive |
|---|---|---|
| MEDI-528 0.3 mg/kg | Experimental | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose Receives: Biological: MEDI-528 0.3 mg/kg |
| MEDI-528 1 mg/kg | Experimental | MEDI-528 (1 mg/kg) administered as a single, SC dose Receives: Biological: MEDI-528 1 mg/kg |
| MEDI-528 3 mg/kg | Experimental | MEDI-528 (3 mg/kg) administered as a single, SC dose Receives: Biological: MEDI-528 3 mg/kg |
| MEDI-528 9 mg/kg | Experimental | MEDI-528 (9 mg/kg) administered as a single, SC 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
Measured: Days 0, 1, 7, 14, and 28
Incidence of Clinically Significant Changes From Baseline in Neurologic Exam
Number of participants with clinically significant changes from baseline in neurologic exam
Measured: Days 0, 7, 14, 21, 28, 42, and 84
Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain
Number of participants with changes from baseline in the Day 28 MRI of the brain
Measured: Days 0 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 with ADA to MEDI-528
Measured: Days 0, 14, 28, 42, and 84
Time to Observed Maximum Serum Concentration (Tmax)
Tmax of MEDI-528
Measured: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Observed Maximum Serum Concentration (Cmax)
Cmax of MEDI-528
Measured: Days 0, 1, 2, 3, 4, 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, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528
AUC(0-infinity) of MEDI-528
Measured: Days 0, 1, 2, 3, 4, 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, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Total Body Clearance (CL)
CL of MEDI-528
Measured: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Half-life (T1/2)
T1/2 of MEDI-528
Measured: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F)
Vz/F of MEDI-528
Measured: Days 0, 1, 2, 3, 4, 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 posted28 Jun 2005 (estimated)
- Study startJun 2005
- Primary completionApr 2006
- Study completionJul 2006
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 HealthyStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara White, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116168
- Sponsor's protocol ID
- MI-CP109
- Status last verified
- Oct 2013
- First submitted
- 27 Jun 2005
- Last updated
- 11 Dec 2013
- 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 11 Dec 2013. 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, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528, a Humanized Monoclonal Anti-Interleukin-9 Antibody, in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00116168
- Acronym / sponsor ID
- MI-CP109
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 28 Jun 2005 (estimated)
- Results
- Posted 11 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.
Detailed description
The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single SC doses of MEDI-528 administered to healthy adult volunteers in four dose groups.
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, subcutaneous (SC) dose |
| MEDI-528 1 mg/kg | Experimental | Biological: MEDI-528 1 mg/kgMEDI-528 (1 mg/kg) administered as a single, SC dose |
| MEDI-528 3 mg/kg | Experimental | Biological: MEDI-528 3 mg/kgMEDI-528 (3 mg/kg) administered as a single, SC dose |
| MEDI-528 9 mg/kg | Experimental | Biological: MEDI-528 9 mg/kgMEDI-528 (9 mg/kg) administered as a single, SC dose |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Males and females age 19 up to, and including, 49 years of age at the time of the first dose of study drug
- Weight less than 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 two years post-menopausal or an FSH≥40 mIu/mL, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, 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 the study period of 84 days. 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 Study Day 84 after their dose of study drug.
Key exclusion criteria (18 listed)
- Acute illnesses or evidence of significant active infection, such as fever greater than or equal to 38.0 C (100.5°F) at the start of the study
- Use of prescription medications, other than oral contraceptives, in the 28-day period before Study Day 0
- Any blood donation or significant loss of blood within 6 months of time of entry into the study
- History of immunodeficiency or receipt of immunosuppressive drugs
- History of allergy or reaction to any component of the MEDI-528 formulation
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, subcutaneous (SC) dose | Biological | MEDI-528 0.3 mg/kg |
| MEDI-528 1 mg/kgMEDI-528 (1 mg/kg) administered as a single, SC dose | Biological | MEDI-528 1 mg/kg |
| MEDI-528 3 mg/kgMEDI-528 (3 mg/kg) administered as a single, SC dose | Biological | MEDI-528 3 mg/kg |
| MEDI-528 9 mg/kgMEDI-528 (9 mg/kg) administered as a single, SC 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, 1, 7, 14, and 28
Number of participants with troponin levels greater than upper limit of normal
Incidence of Clinically Significant Changes From Baseline in Neurologic Exam
Time frame: Days 0, 7, 14, 21, 28, 42, and 84
Number of participants with clinically significant changes from baseline in neurologic exam
Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain
Time frame: Days 0 and 28
Number of participants with changes from baseline in the Day 28 MRI of the brain
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 0, 14, 28, 42, and 84
Time to Observed Maximum Serum Concentration (Tmax)
Time frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Observed Maximum Serum Concentration (Cmax)
Time frame: Days 0, 1, 2, 3, 4, 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, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528
Time frame: Days 0, 1, 2, 3, 4, 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, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Total Body Clearance (CL)
Time frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Half-life (T1/2)
Time frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F)
Time frame: Days 0, 1, 2, 3, 4, 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 11 Dec 2013.
- 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.
Barbara White, M.D. study director
MedImmune LLC
2 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-528 0.3 mg/kg, MEDI-528 1 mg/kg and MEDI-528 3 mg/kg in people with Healthy, run by MedImmune LLC at 2 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 9 inclusion and 18 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 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 11 Dec 2013). 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 5 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 NCT00116168, 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 11 Dec 2013.