Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers
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|ClinicalTrials.gov Identifier: NCT01453907|
Recruitment Status : Completed
First Posted : October 18, 2011
Last Update Posted : November 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anthrax||Drug: ETI-204, "Anthim" Drug: placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||December 2012|
Drug: ETI-204, "Anthim"
intravenously, single dose
Other Name: ETI-204
|Sham Comparator: placebo||
intravenously, single dose
- Primary Objective [ Time Frame: 71 days ]To evaluate the safety of increasing doses of ETI-204 in healthy subjects
- Secondary Objective [ Time Frame: 71 days ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453907
|United States, Kansas|
|Overland Park, Kansas, United States, 66211|
|Principal Investigator:||Eleanor A Lisbon, M.D., M.P.H||Quintiles Phase One Services|