NCT00829582

Brief Summary

Title: Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Phase I Study of the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Dose of ETI-204 (AnthimTM) Population: This study will determine the safety, tolerability and pharmacokinetics of a single iv dose of ETI-204 in subjects 18 to 50 years of age. Three cohorts will be studied sequentially: subjects receiving 120 mg, 240 mg and 360 mg of ETI-204. The study will be randomized, double-blind, and stratified by gender. Each cohort will contain 15 subjects (including at least four females), twelve who will receive ETI-204 and three who will receive placebo. Study Objectives: To determine the safety, tolerability and pharmacokinetics of ETI-204 following a single intravenous administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2009

Typical duration for phase_1 healthy-volunteers

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

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 14, 2017

Status Verified

January 1, 2010

Enrollment Period

5 months

First QC Date

January 26, 2009

Last Update Submit

November 9, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Evidence of clinical safety following the infusion

    42 days

Secondary Outcomes (1)

  • immunogenicity

    42-70 days

Study Arms (2)

ETI-204

EXPERIMENTAL

ETI-204, Anthim

Drug: ETI-204, "Anthim"

placebo

SHAM COMPARATOR
Other: placebo

Interventions

ETI-204, "Anthim"DRUG

single intravenous infusion of 120, 240 or 360 mg of ETI-204

ETI-204
placeboOTHER

single intravenous infusion

placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female subjects between the ages of 18-50 inclusive at the time of enrollment. In each of the drug cohorts (subgroups), at least three of the subjects must be female.
  • The following screening laboratory parameters must be within 5% of the normal range: CBC (excluding WBC) and coagulation tests (aPTT, PT and INR). Absolute counts of WBC must be within 10% of the normal range. BUN, creatinine, and total and direct bilirubin may be up to 10% above the upper limits of normal. AST, ALT and alkaline phosphatase must be within normal limits. Urinalysis must be within generally accepted normal limits.
  • The values for the following tests at screening are to be:
  • G-6-P dehydrogenase - normal HBsAg - negative HBV - negative (except immunized subjects may have positive anti-HBs) Anti-HCV - negative Anti-HIV (HIV antibody test) - negative Urine drug screen (including cotinine) - negative
  • Female subjects must agree to practice heterosexual abstinence or to use a licensed, effective form of birth control (e.g., oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, intrauterine contraceptive device, Depo-Provera®, skin patch, vaginal ring, or cervical cap) for at least 30 days prior to enrollment and for the duration of the study, including the follow-up period. Females using hormonal contraceptives must agree to use at least one other method for at least 30 days prior to enrollment and for the duration of the study, including the follow-up period.
  • Female subjects must have a negative pregnancy test.
  • No history of hospitalization for illness within the six months prior to study enrollment.
  • Nonsmoker or ex-smoker. If a subject is an ex-smoker, he/she must not have used nicotine for at least 6 months prior to enrollment. This will be confirmed by a negative urine test for cotinine. Exceptions may be made for sporadic users with negative urine cotinine tests; this will be determined on a case-by-case basis.
  • Able to spend the two days specified in the study schedule confined in a facility under study rules.
  • Able to read, understand and sign the informed consent form

You may not qualify if:

  • Routine consumption of any medication (prescription or OTC), vitamin, mineral, or dietary supplement, for one week before and during the study. The sole exceptions are hormonal contraceptive agents, as detailed above. The withdrawal time for any prescription medication should be no less than 1 week prior to the beginning of the study.
  • Blood pressure greater than 139 mm Hg systolic and 89 mm Hg diastolic. Repeat measurements are allowed.
  • Contraindication to the use of any monoclonal antibody: history of allergic reactions to any biologic or formulation component
  • Medical condition that in the Investigator's opinion could adversely impact the subject's participation, safety or conduct of the study.
  • Subject has taken an investigational medication in the previous three months.
  • The subject has a history of drug or alcohol abuse within the past two years.
  • The subject is female and plans to become pregnant during the whole study period or 6 months.
  • Calculated Body Mass Index (BMI) greater than 35.0 or less than 18.5.
  • The subject has been previously vaccinated with anthrax or has participated in clinical research involving anthrax.
  • Any ECG abnormality except for the following:
  • Sinus bradycardia, no lower than 46 beats per minute in younger, athletic subjects
  • Sinus tachycardia if the heart rate is within normal limits when vital signs are measured
  • Respiratory arrhythmia
  • Mild first degree A-V block (P-R interval \< 0.23 sec)
  • Incomplete right bundle branch block
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osu, 5084 Graves 333 W Tenth Ave

Columbus, Ohio, 43210, 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

Interventions

obiltoxaximab

Study Officials

  • Glen Apseloff, MD

    OSU

    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

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

November 14, 2017

Record last verified: 2010-01

Locations

US(1)