Status:
COMPLETED
Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers
Lead Sponsor:
Elusys Therapeutics
Conditions:
Anthrax
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 randomiz...
Detailed Description
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 ap...
Eligibility Criteria
Inclusion
- Subjects who meet all of the criteria shown below may be included in the study.
- Healthy male or female subjects between 18 and 65 years of age.
- Subjects with a body mass index (BMI) \> 18.5 and \< 35 kg/m2.
- Female subjects of childbearing potential (not post-menopausal or surgically sterile) must have a negative urine β-hCG pregnancy test at Screening.
- Female subjects of childbearing potential (not post-menopausal or surgically sterile) must use a medically accepted method of contraception for the duration of the study, including the 70-day follow-up period. Acceptable methods of contraception include abstinence, a barrier method with spermicide, an intrauterine device (IUD) or a hormonal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method.
- Male subjects must agree to practice abstinence or to use a condom with spermicide for the duration of the study, including the 70-day follow-up period.
- The subject has no clinically significant abnormalities on the clinical laboratory tests (hematology, clinical chemistry, or urinalysis) or ECG at Screening.
- Subject provides written informed consent.
Exclusion
- Subjects who meet any of the criteria below will be excluded from participation in the study.
- Subject requires regular use of a medication for a chronic condition.
- Subject has a clinically significant comorbidity that would interfere with the completion of the study procedures or objectives, or would compromise the subject's safety.
- Subject has a systolic blood pressure (BP) \> 140 mm Hg or a diastolic BP \> 90 mm Hg.
- Subject has a systolic BP \< 90 mm Hg.
- Subject has current suspected drug or alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) (American Psychiatric Association 2000).
- Subject has a positive alcohol or drug test result at Screening and on Day -1
- Subject has received an investigational agent within 30 days or 5 half-lives (whichever is longer) of Screening.
- Subject has congenital or acquired immunodeficiency syndrome.
- Subject has a positive test for Hepatitis B (surface antigen), Hepatitis C, or human immunodeficiency virus (HIV) at Screening.
- Subject smokes \> 3 cigarettes per day.
- Subject has ever had prior treatment for anthrax exposure, prior anthrax infection, prior immunization with any anthrax vaccine or prior treatment with an investigational anthrax treatment
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01453907
Start Date
October 1 2011
End Date
December 1 2012
Last Update
November 14 2017
Active Locations (1)
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1
Quintiles
Overland Park, Kansas, United States, 66211