Respiratory Syncytial Virus
Conditions
Keywords
Respiratory Syncytial Virus
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.
Interventions
DRUGPlacebo
Placebo
DRUGMEDI-557
MEDI-557 low-dose
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | from time of informed consent through 360 days post dose (approximately 1 year total) | The occurrence of AEs and SAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed