Placebo-Controlled, Sequential Group, Single Dose, Dose-Escalation Study to Evaluate the Safety and PK of ETI-204
This study will determine the safety and PK of a single IV dose of ETI-204 in subjects 18 to 65 years of age. Three cohorts will be studied with subjects receiving ETI-204. This study will be randomized, double-blind and stratified by gender. Each cohort will contain 36 subjects (including at least four females), 30 who will receive ETI-204 and six who will receive placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Single Dose, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of ETI-204 in Healthy Subjects|
- Primary Objective [ Time Frame: 71 days ] [ Designated as safety issue: Yes ]To evaluate the safety of increasing doses of ETI-204 in healthy subjects
- Secondary Objective [ Time Frame: 71 days ] [ Designated as safety issue: No ]
To evaluate the PK of increasing singles doses of ETI-204 in healthy subjects.
To evaluate the immunogenicity of ETI-204 following IV administration in healthy subjects.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Drug: ETI-204, "Anthim"
intravenously, single dose
Other Name: ETI-204
|Sham Comparator: placebo||
intravenously, single dose
Other Name: placebo
Protocol AH-105 is a single center, randomized, double-blind, placebo-controlled, sequential, dose escalation study. It will evaluate the safety and PK of single IV doses of ETI-204 administered to approximately 108 healthy male and female subjects. At each dose level, 30 healthy subjects, including at least 4 females, will be randomly assigned to active drug, and at least 6 healthy subjects of both genders will be randomly assigned to matching placebo.
Description of Agent: ETI-204 is a monoclonal antibody (mAb) to protective antigen (PA) from Bacillus anthracis.
The study will consist of 3 phases: Screening, Inpatient, and Outpatient Follow-up. Enrollment criteria will be determined during the 21-day Screening Phase (Visit 1), following by a 3 night inpatient phase where eligible subjects will receive a single dose of IV ETI-204 or matching placebo as described above and undergo routine safety monitoring, dermatologic assessments, and blood draws at pre-specified time points. Subjects will be discharged from the center after collection of the 48-hour PK sample. During the subsequent 70-day outpatient follow-up phase, subjects will return to the center on Days 8, 15, 29, 43 and 71 for clinical laboratory testing (hematology and clinical chemistry), physical examinations and vital signs measurements, and routine safety monitoring. Blood samples for PK and anti-drug antibodies (ADA)will also be collected. The 70 day post-dosing follow-up in this study was selected to allow characterization for the PK profile of ETI-204 and the potential development of ADA.
|Contact: Eleanor A Lisbon, M.D., M.P.H||913 email@example.com|
|United States, Kansas|
|Overland Park, Kansas, United States, 66211|
|Contact: Eleanor A Lisbon, M.D., M.P.H 913-708-7551 firstname.lastname@example.org|
|Principal Investigator: Eleanor A Lisbon, M.D., M.P.H|
|Principal Investigator:||Eleanor A Lisbon, M.D., M.P.H||Quintiles Phase One Services|