A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00578682
First received: December 19, 2007
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

To evaluate the safety and tolerability of a single IV dose of MEDI-557.


Condition Intervention Phase
Healthy
Biological: MEDI-557
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • The occurrence of AEs from the period immediately following study drug administration [ Time Frame: through 28 days after dosing ] [ Designated as safety issue: Yes ]
  • The occurrence of laboratory AEs from the period immediately following study drug administration [ Time Frame: through 90 days after dosing ] [ Designated as safety issue: Yes ]
  • The occurrence of SAEs from the period immediately following study drug administration [ Time Frame: through 240 days after dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The single-dose pharmacokinetic parameters of IV MEDI-557 and motavizumab monitored using noncompartmental analysis. [ Time Frame: Day 240 ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: December 2007
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single IV dose of 0.3 mg/kg MEDI-557
Biological: MEDI-557
Single IV dose of 0.3 mg/kg
Experimental: 2
Single IV dose of 3 mg/kg MEDI-557
Biological: MEDI-557
Single IV dose of 3 mg/kg
Other Name: motavizumab
Experimental: 3
Single IV dose of 15 mg/kg MEDI-557
Biological: MEDI-557
Single IV dose of 15 mg/kg
Other Name: motavizumab
Experimental: 4
Single IV dose of 30 mg/kg MEDI-557
Biological: MEDI-557
Single IV dose of 30 mg/kg
Other Name: motavizumab

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578682

Locations
United States, Florida
Covance Daytona Beach
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: M. Pamela Griffin, M.D. MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: M. Pamela Griffin, M.D., MedImmune
ClinicalTrials.gov Identifier: NCT00578682     History of Changes
Other Study ID Numbers: MI-CP144
Study First Received: December 19, 2007
Last Updated: November 22, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 20, 2014