MEDI-557 Adult Dosing (CD-1092)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01562938
First received: March 7, 2012
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

This is a Phase 1, double-blind, placebo controlled study enrolling 42 healthy adult subjects (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive MEDI-557 or placebo. Subjects will receive 1 intravenous dose on Study Day 1. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.


Condition Intervention Phase
Respiratory Syncytial Virus
Drug: Placebo
Drug: MEDI-557
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of MEDI-557, a Humanized Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus (RSV), Administered to Healthy Adults

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: from time of informed consent through 360 days post dose (approximately 1 year total) ] [ Designated as safety issue: Yes ]
    The occurrence of AEs and SAEs

  • Safety and Tolerability [ Time Frame: Pre-dose; every 30 minutes during infusion; up to 24 hours after end of infusion ] [ Designated as safety issue: Yes ]
    Vital sign measurements - blood pressure, heart rate, respiratory rate, temperature

  • Safety and Tolerability [ Time Frame: from Day 1 (pre-dose) through 360 days post dose. ] [ Designated as safety issue: Yes ]
    Clinical lab measurements - chemistry, hematology; Urinalysis


Secondary Outcome Measures:
  • Pharmacokinetic Assessments - Serum [ Time Frame: 1st dose through 360 days post dose ] [ Designated as safety issue: Yes ]
    Maximum serum concentration; Time to maximum serum concentration; Terminal phase elimination half-life; Area under the serum concentration-time curve from time zero to last measurable time point; Area under the serum concentration-time curve from time zero to infinity; Clearance; Volume of distribution

  • Occurrence of anti-MEDI-557 antibody - Serum and Nasal Wash [ Time Frame: 1st dose through 360 days post dose ] [ Designated as safety issue: Yes ]
    MEDI-557 concentrations in serum and nasal wash through 360 days post dose

  • Pharmacokinetic Assessments - Nasal Wash [ Time Frame: 1st dose through 360 days post dose ] [ Designated as safety issue: Yes ]
    Maximum nasal wash concentration; Time to maximum nasal wash concentration; Area under the nasal wash conentration-time curve from time zero to last measurable time point

  • anti-RSV antibody in Serum and Nasal Wash [ Time Frame: 1st dose through 360 days post dose ] [ Designated as safety issue: Yes ]
    To evaluate anti-RSV antibodies (F-specific IgG and neutralizing) in serum and nasal wash.


Enrollment: 42
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Active Comparator: MEDI-557 low-dose Drug: MEDI-557
MEDI-557 low-dose
Active Comparator: MEDI-557 high-dose Drug: MEDI-557
MEDI-557 high-dose

Detailed Description:

A Phase 1, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of MEDI-557 administered IV to healthy adult subjects (18-45yrs). A maximum of 42 subjects from 1 site will be enrolled in a 2:3:2 ratio (12 placebo, 18 MEDI-557 low-dose, 12 MEDI-557 high-dose) to allow for greater data collection in the low-dose group. Subjects are evaluated for safety from time of Informed Consent through Study Day 360 post dose.

  Eligibility

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

Inclusion Criteria:

  • 18-45 years
  • written informed consent obtained from subject prior to performing any protocol related procedures
  • healthy by medical history and physical exam
  • females of child-bearing potential must use 2 effective methods of birth control for 14 days prior to 1st dose and through 1 year after administration of study drug
  • nonsterilized, sexually active males with female partner of child-bearing potential must use 2 effective methods of birth control from Day 1 through Day 361
  • weight </= 110kg with a body mass index of <32kg/m2
  • ability to complete a follow-up period of approximately 360 days

Exclusion Criteria:

  • inability to complete a follow-up period of 360 days
  • any condition in the opinion of investigator that would interfere with evaluation of IP or interpretation of subject safety or study results
  • concurrent enrollment in another clinical study
  • employees of the site or other individuals involved with the conduct of the study or immediate family members of such individuals
  • receipt of immunoglobulin or blood products within 60 days prior to randomziation
  • receipt of any investigational drug therapy within 6 months prior to IP dosing
  • clinically abnormal ECG at screening
  • blood donation in excess of 400mL, wihtin 6 months prior to randomization
  • previous receipt fo biologics
  • history of immunodeficiency
  • history of allergic disease or reactions likely to be exacerbated by any component of the IP
  • previous medical history or evidence of interurrent illness that may compromise the safety of the subject
  • positive lab test for Hep A, B, C or HIV
  • pregnancy or nursing mother
  • history of alcohol or drug abuse within past 2 years
  • positive urine Class A drug screen
  • acute illness within 7 days prior to randomization
  • fever >/= 99.5F witin 7 days prior to randomization
  • any drug therapy within 7 days prior to randomization
  • systolic BP >150mmHG and/or diastolic BP>90mmHg
  • receipt of vaccine within 14 days prior to randomization
  • abnormal study labs (hem/wbc/platelet/BUN - see protocol for specific information)
  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: NCT01562938

Locations
United States, Florida
Research Site
Miami, Florida, United States
Sponsors and Collaborators
MedImmune LLC
Investigators
Principal Investigator: Robert Feldman, MD Research Site
Study Director: Hasan Jafri MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01562938     History of Changes
Other Study ID Numbers: CD-ID-MEDI-557-1092
Study First Received: March 7, 2012
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Respiratory Syncytial Virus

ClinicalTrials.gov processed this record on August 28, 2014