MEDI-557 Adult Dosing

NCT01562938 | Completed Phase 1

• 1 other identifier: CD-ID-MEDI-557-1092
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Syncytial Virus

Keywords

Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Pharmacokinetic Assessments - Serum

  1st dose through 360 days post dose

• Occurrence of anti-MEDI-557 antibody - Serum and Nasal Wash

  1st dose through 360 days post dose

• Pharmacokinetic Assessments - Nasal Wash

  1st dose through 360 days post dose

• anti-RSV antibody in Serum and Nasal Wash

  1st dose through 360 days post dose

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

MEDI-557 low-dose

ACTIVE COMPARATOR

Drug: MEDI-557

MEDI-557 high-dose

ACTIVE COMPARATOR

Drug: MEDI-557

Interventions

Placebo DRUG

Placebo

Placebo

MEDI-557 DRUG

MEDI-557 low-dose

MEDI-557 low-dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

Research Site

Miami, Florida, United States

Location

Study Officials

• Robert Feldman, MD

  Research Site

  PRINCIPAL INVESTIGATOR

• Hasan Jafri

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 26, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 7, 2013

Record last verified: 2013-10

Locations

US (1)