A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557
November 22, 2011 updated by: MedImmune LLC
A Phase I, Randomized, Double-Blind, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557, A Humanized Monoclonal Antibody With an Extended Half-Life Against Respiratory Syncytial Virus (RSV), in Healthy Adults
To evaluate the safety and tolerability of a single IV dose of MEDI-557.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this study is to evaluate the safety and tolerability of a single IV dose of MEDI-557 administered to healthy adult subjects in 4 dose cohorts.
Study Type
Interventional
Enrollment (Actual)
31
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
-
Daytona Beach, Florida, United States, 32117
- Covance Daytona Beach
-
-
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 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 through 45 years at the time of study entry;
- Weight ≤ 90 kg;
- Healthy by medical history and physical examination;
- Normotensive (systolic blood pressure [BP] < 150 mmHg and diastolic BP <90 mmHg);
- Normal electrocardiogram (ECG) at screening (must occur within 21 days before entry into the study);
- Normal spirometry at screening (must occur within 21 days before entry into the study). Normal spirometry is defined as FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) ≥ 80% predicted and an FEV1/FVC > 70%.
- Written informed consent obtained from the subject;
- Sexually active females, unless surgically sterile, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner or sterile sexual partner) for 14 days prior to study drug dosing, must agree to continue using such precautions for 1 year after administration of study drug, and must have a negative serum pregnancy test within 3 days prior to study drug dosing and a negative urine pregnancy test on the day of study drug administration; and
- Ability to complete follow-up period of 240 days as required by the protocol.
Exclusion Criteria:
- Acute illness at study entry;
- Fever ≥ 99.5°F at study entry;
- Any drug therapy within 7 days prior to Study Day 0 (except contraceptives);
- Blood donation in excess of 400 mL within 6 months prior to study entry;
- Receipt of immunoglobulin or blood products within 60 days prior to study entry;
- Receipt of any investigational drug therapy or standard vaccine within 120 days prior to study drug dosing through 240 days after study drug dosing;
- Previous receipt of palivizumab or motavizumab; History of immunodeficiency;
- History of allergic disease or reactions likely to be exacerbated by any component of either study drug;
- Previous medical history or evidence of an intercurrent illness that may compromise the safety of the subject in the study;
- Evidence of any systemic disease on physical examination;
- Evidence of infection (ie, positive laboratory test result) with hepatitis A, B, or C virus or human immunodeficiency virus-1 (HIV-1);
- At screening (must be within 21 days before entry into the study) any of the following: hemoglobin < 12.0 gm/dL, white blood cell count (WBC) < 4,000/mm3, platelet count < 120,000/mm3 (or laboratory normal values); aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), serum creatinine > upper limit of normal (ULN); other abnormal laboratory values in the screening panel which, in the opinion of the principal investigator, are judged to be clinically significant; other abnormal laboratory values in the screening panel which, in the opinion of the principal investigator, are judged to potentially confound analysis of study results;
- Pregnancy, or nursing mother;
- History of alcohol or drug abuse within the past 2 years; or
- History of asthma, seasonal allergies, or exercise-induced wheezing.
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: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Single IV dose of 0.3 mg/kg MEDI-557
|
Single IV dose of 3 mg/kg
Other Names:
Single IV dose of 15 mg/kg
Other Names:
Single IV dose of 30 mg/kg
Other Names:
Single IV dose of 0.3 mg/kg
|
|
Experimental: 2
Single IV dose of 3 mg/kg MEDI-557
|
Single IV dose of 3 mg/kg
Other Names:
Single IV dose of 15 mg/kg
Other Names:
Single IV dose of 30 mg/kg
Other Names:
Single IV dose of 0.3 mg/kg
|
|
Experimental: 3
Single IV dose of 15 mg/kg MEDI-557
|
Single IV dose of 3 mg/kg
Other Names:
Single IV dose of 15 mg/kg
Other Names:
Single IV dose of 30 mg/kg
Other Names:
Single IV dose of 0.3 mg/kg
|
|
Experimental: 4
Single IV dose of 30 mg/kg MEDI-557
|
Single IV dose of 3 mg/kg
Other Names:
Single IV dose of 15 mg/kg
Other Names:
Single IV dose of 30 mg/kg
Other Names:
Single IV dose of 0.3 mg/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The occurrence of AEs from the period immediately following study drug administration
Time Frame: through 28 days after dosing
|
through 28 days after dosing
|
|
The occurrence of laboratory AEs from the period immediately following study drug administration
Time Frame: through 90 days after dosing
|
through 90 days after dosing
|
|
The occurrence of SAEs from the period immediately following study drug administration
Time Frame: through 240 days after dosing
|
through 240 days after dosing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The single-dose pharmacokinetic parameters of IV MEDI-557 and motavizumab monitored using noncompartmental analysis.
Time Frame: Day 240
|
Day 240
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: M. Pamela Griffin, M.D., MedImmune LLC
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
December 1, 2007
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
December 19, 2007
First Submitted That Met QC Criteria
December 19, 2007
First Posted (Estimate)
December 21, 2007
Study Record Updates
Last Update Posted (Estimate)
November 23, 2011
Last Update Submitted That Met QC Criteria
November 22, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- MI-CP144
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.