- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00192296
Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers
February 4, 2014 updated by: MedImmune LLC
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
24
Phase
- 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
-
-
Louisiana
-
New Orleans, Louisiana, United States
- MDS Pharma Services
-
-
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
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MEDI-528 0.3 mg/kg
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
|
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
|
Experimental: MEDI-528 1 mg/kg
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
MEDI-528 (1 mg/kg) administered as a single, IV dose
|
Experimental: MEDI-528 3 mg/kg
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
MEDI-528 (3 mg/kg) administered as a single, IV dose
|
Experimental: MEDI-528 9 mg/kg
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
MEDI-528 (9 mg/kg) administered as a single, IV dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Events
Time Frame: Days 0 - 84
|
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
|
Days 0 - 84
|
Incidence of Serious Adverse Events
Time Frame: Days 0 - 84
|
Number of participants experiencing serious adverse events
|
Days 0 - 84
|
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)
|
Days 0, 7, 14, 21, and 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Time Frame: Days 14, 28, 42, and 84
|
Number of participants who had ADA detected at each time point
|
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
|
Tmax of MEDI-528
|
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
|
Cmax of MEDI-528
|
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
|
AUC(0-t) of MEDI-528
|
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
|
AUC(0-infinity) of MEDI-528
|
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
|
AUC(ext) of MEDI-528
|
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
|
CL of MEDI-528
|
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
|
T1/2 of MEDI-528
|
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
|
Vz of MEDI-528
|
Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ramon Vargas, MD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
August 1, 2004
Primary Completion (Actual)
February 1, 2005
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
March 6, 2014
Last Update Submitted That Met QC Criteria
February 4, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- MI-CP105
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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