Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 in Healthy Adults
January 28, 2009 updated by: MedImmune LLC
A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 (NUMAX TM), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Healthy Adults
To provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524 administered initially as a single dose to healthy adults in a dose escalation safety study before testing in the targeted pediatric population.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
Florida
-
Miami, Florida, United States, 33181
- SFBC International, Inc
-
-
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:
- Volunteers must meet all of the following criteria:
- Age 18 through 49 years at the time of administration of study drug
- Weight £90 kg
- Healthy by medical history and physical examination
- Normal electrocardiogram (EKG) at screening (must be within 21 days before entry into the study)
- Written informed consent obtained from the volunteer
- Sexually active females, unless surgically sterile, must have used an effective method of avoiding pregnancy (including oral 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 14 days prior to the administration of study drug, must agree to continue using such precautions for 30 days after administration of study drug, and must have a negative serum pregnancy test within 7 days prior to the administration of study drug and a negative urine pregnancy test on the day of study drug administration.
- Ability to complete the follow-up period of 90 days (single-dose groups) or 120 days (two-dose group) as required by the protocol
Exclusion Criteria:
- Volunteers must have none of the following:
- Acute illness at the time of entry into the study
- Temperature ³99.5°F at the time of entry into the study
- Any drug therapy within 7 days prior to Study Day 0 (except for certain medications such as contraceptives, topical corticosteroids, or infrequent use of over-the-counter headache medications, following approval of the sponsor)
- Blood donation in excess of 400 mL within 6 months of the time of entry into the study
- Receipt of immunoglobulin or blood products within 60 days before entry into the study
- Receipt of any investigational drug therapy or standard vaccine within 120 days before administration of study drug in this protocol through 60 days after the final dose of study drug
- History of immunodeficiency or receipt of immunosuppressive drugs
- History of allergic disease or reactions likely to be exacerbated by any component of the study drug
- Previous medical history or evidence of an intercurrent illness that may compromise the safety of the volunteer in the study
- Evidence of any systemic disease on physical examination
- Evidence of infection with hepatitis A, B, or C virus or HIV-1
- At screening (must be within 7 days before study dose administration) any of the following: CBC: Hgb < 12.0 gm/dL; WBC < 4,000/mm3; platelet count < 120,000/mm3 (or laboratory normal values); AST, ALT, BUN, creatinine > 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.
- Nursing mother
- History of alcohol or drug abuse within the past 2 years
- The presence of any condition or concern which in the opinion of the principal 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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
MEDI-524 (Numax-TM)
|
Grp.1: 3 mg/kg IV (single dose)
Grp. 2: 15 mg/kg IV (single dose)
Grp. 3: 30 mg/kg IV (single dose)
Grp. 4: 3 mg/kg IM (single dose)
Grp.5: 3 mg/kg IM (two doses)
|
|
Experimental: 2
MEDI-524 (Numax-TM)
|
Grp.1: 3 mg/kg IV (single dose)
Grp. 2: 15 mg/kg IV (single dose)
Grp. 3: 30 mg/kg IV (single dose)
Grp. 4: 3 mg/kg IM (single dose)
Grp.5: 3 mg/kg IM (two doses)
|
|
Experimental: 3
MEDI-524 (Numax-TM)
|
Grp.1: 3 mg/kg IV (single dose)
Grp. 2: 15 mg/kg IV (single dose)
Grp. 3: 30 mg/kg IV (single dose)
Grp. 4: 3 mg/kg IM (single dose)
Grp.5: 3 mg/kg IM (two doses)
|
|
Experimental: 4
MEDI-524 (Numax-TM)
|
Grp.1: 3 mg/kg IV (single dose)
Grp. 2: 15 mg/kg IV (single dose)
Grp. 3: 30 mg/kg IV (single dose)
Grp. 4: 3 mg/kg IM (single dose)
Grp.5: 3 mg/kg IM (two doses)
|
|
Experimental: 5
MEDI-524 (Numax-TM)
|
Grp.1: 3 mg/kg IV (single dose)
Grp. 2: 15 mg/kg IV (single dose)
Grp. 3: 30 mg/kg IV (single dose)
Grp. 4: 3 mg/kg IM (single dose)
Grp.5: 3 mg/kg IM (two doses)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety
Time Frame: 30 days after patient's final dose of study drug
|
30 days after patient's final dose of study drug
|
|
Pharmacokinetics
Time Frame: Study Day 0 and 60, 90 days after dose 1; and 7, 30, 60, 90 days after dose 2.
|
Study Day 0 and 60, 90 days after dose 1; and 7, 30, 60, 90 days after dose 2.
|
|
Immunogenicity
Time Frame: 150 days after final dose
|
150 days after final dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Genevieve Losonsky, MD, 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
November 1, 2003
Primary Completion (Actual)
April 1, 2004
Study Completion (Actual)
November 1, 2004
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
January 29, 2009
Last Update Submitted That Met QC Criteria
January 28, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MI-CP101
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.