MEDI-557 Adult Dosing - Full Text View

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 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
Estimated Study Completion Date:	June 2013
Estimated 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:	Elissa Malkin	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:	May 3, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by MedImmune LLC:

Respiratory Syncytial Virus

ClinicalTrials.gov processed this record on May 23, 2013

MEDI-557 Adult Dosing (CD-1092)