NCT01453907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 14, 2017

Status Verified

October 1, 2011

Enrollment Period

8 months

First QC Date

October 14, 2011

Last Update Submit

November 9, 2017

Conditions

Anthrax

Outcome Measures

Primary Outcomes (1)

  • Primary Objective

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

    71 days

Secondary Outcomes (1)

  • Secondary Objective

    71 days

Study Arms (2)

ETI-204

EXPERIMENTAL

ETI-204, Anthim

Drug: ETI-204, "Anthim"

placebo

SHAM COMPARATOR
Drug: placebo

Interventions

ETI-204, "Anthim"DRUG

intravenously, single dose

Also known as: ETI-204
ETI-204
placeboDRUG

intravenously, single dose

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quintiles

Overland Park, Kansas, 66211, United States

Location

Related Publications (1)

  • 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.

    PMID: 27568215DERIVED

MeSH Terms

Conditions

Anthrax

Interventions

obiltoxaximab

Condition Hierarchy (Ancestors)

Bacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Eleanor A Lisbon, M.D., M.P.H

    Quintiles Phase One Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 18, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

November 14, 2017

Record last verified: 2011-10

Locations

US(1)