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
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 April 17, 2014