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Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers

Primary Purpose

Anthrax

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ETI-204, "Anthim"

placebo

About this trial

This is an interventional treatment trial for Anthrax

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Criteria: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

Sites / Locations

Quintiles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ETI-204

placebo

Arm Description

ETI-204, Anthim

Outcomes

Primary Outcome Measures

Primary Objective

To evaluate the safety of increasing doses of ETI-204 in healthy subjects

Secondary Outcome Measures

Secondary Objective

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.

Full Information

NCT ID

NCT01453907

First Posted

October 14, 2011

Last Updated

November 9, 2017

Sponsor

Elusys Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01453907

Brief Title

Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers

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 Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Elusys Therapeutics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anthrax

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ETI-204

Arm Type

Experimental

Arm Description

ETI-204, Anthim

Arm Title

placebo

Arm Type

Sham Comparator

Intervention Type

Drug

Intervention Name(s)

ETI-204, "Anthim"

Other Intervention Name(s)

ETI-204

Intervention Description

intravenously, single dose

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

intravenously, single dose

Primary Outcome Measure Information:

Title

Primary Objective

Description

To evaluate the safety of increasing doses of ETI-204 in healthy subjects

Time Frame

71 days

Secondary Outcome Measure Information:

Title

Secondary Objective

Description

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.

Time Frame

71 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eleanor A Lisbon, M.D., M.P.H

Organizational Affiliation

Quintiles Phase One Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Quintiles

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27568215

Citation

Nagy CF, Leach TS, Hoffman JH, Czech A, Carpenter SE, Guttendorf R. Pharmacokinetics and Tolerability of Obiltoxaximab: A Report of 5 Healthy Volunteer Studies. Clin Ther. 2016 Sep;38(9):2083-2097.e7. doi: 10.1016/j.clinthera.2016.07.170. Epub 2016 Aug 24.

Results Reference

derived

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Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers

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