MEDI-557 Adult Dosing
- Conditions
- Respiratory Syncytial Virus
- Interventions
- Drug: PlaceboDrug: MEDI-557
- Registration Number
- NCT01562938
- Lead Sponsor
- MedImmune LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo MEDI-557 low-dose MEDI-557 - MEDI-557 high-dose MEDI-557 -
- Primary Outcome Measures
Name Time Method Safety and Tolerability from Day 1 (pre-dose) through 360 days post dose. Clinical lab measurements - chemistry, hematology; Urinalysis
- Secondary Outcome Measures
Name Time Method Pharmacokinetic Assessments - Serum 1st dose through 360 days post dose 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 1st dose through 360 days post dose MEDI-557 concentrations in serum and nasal wash through 360 days post dose
Pharmacokinetic Assessments - Nasal Wash 1st dose through 360 days post dose 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 1st dose through 360 days post dose To evaluate anti-RSV antibodies (F-specific IgG and neutralizing) in serum and nasal wash.
Trial Locations
- Locations (1)
Research Site
🇺🇸Miami, Florida, United States