MEDI-557 Adult Dosing (CD-1092)

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus
• Intervention / Treatment: Drug: Placebo; Drug: MEDI-557; Drug: MEDI-557

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo
ACTIVE_COMPARATOR: MEDI-557 low-dose	Drug: MEDI-557; MEDI-557 low-dose; Drug: MEDI-557; MEDI-557 high-dose
ACTIVE_COMPARATOR: MEDI-557 high-dose	Drug: MEDI-557; MEDI-557 low-dose; Drug: MEDI-557; MEDI-557 high-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	The occurrence of AEs and SAEs	from time of informed consent through 360 days post dose (approximately 1 year total)
Safety and Tolerability	Vital sign measurements - blood pressure, heart rate, respiratory rate, temperature	Pre-dose; every 30 minutes during infusion; up to 24 hours after end of infusion
Safety and Tolerability	Clinical lab measurements - chemistry, hematology; Urinalysis	from Day 1 (pre-dose) through 360 days post dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Assessments - Serum	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	1st dose through 360 days post dose
Occurrence of anti-MEDI-557 antibody - Serum and Nasal Wash	MEDI-557 concentrations in serum and nasal wash through 360 days post dose	1st dose through 360 days post dose
Pharmacokinetic Assessments - Nasal Wash	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	1st dose through 360 days post dose
anti-RSV antibody in Serum and Nasal Wash	To evaluate anti-RSV antibodies (F-specific IgG and neutralizing) in serum and nasal wash.	1st dose through 360 days post dose

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Investigators: Principal Investigator: Robert Feldman, MD, Research Site; Study Director: Hasan Jafri, MedImmune LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (ESTIMATE): March 26, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 7, 2013
• Last Update Submitted That Met QC Criteria: October 4, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Respiratory Syncytial Virus
• Other Study ID Numbers: CD-ID-MEDI-557-1092