Clinical trial NCT01562938: MEDI-557 Adult Dosing
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus
Keywords: Respiratory Syncytial Virus
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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)

Primary outcomes:
measure: Safety and Tolerability
timeFrame: from time of informed consent through 360 days post dose (approximately 1 year total)
measure: Safety and Tolerability
timeFrame: Pre-dose; every 30 minutes during infusion; up to 24 hours after end of infusion
measure: Safety and Tolerability
timeFrame: from Day 1 (pre-dose) through 360 days post dose.
Secondary outcomes:
measure: Pharmacokinetic Assessments - Serum
timeFrame: 1st dose through 360 days post dose
measure: Occurrence of anti-MEDI-557 antibody - Serum and Nasal Wash
timeFrame: 1st dose through 360 days post dose
measure: Pharmacokinetic Assessments - Nasal Wash
timeFrame: 1st dose through 360 days post dose
measure: anti-RSV antibody in Serum and Nasal Wash
timeFrame: 1st dose through 360 days post dose
Other outcomes:
Locations:
city: Miami
country: United States
facility: Research Site
state: Florida
Study officials:
affiliation: Research Site
name: Robert Feldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MedImmune LLC
name: Hasan Jafri
role: STUDY_DIRECTOR
References: