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Antiviral

ETI-204 for Inhalation Anthrax

Phase 1
Waitlist Available
Led By Alex King, MD
Research Sponsored by Elusys Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on days 2, 8, 15, 29, 43, and 71.
Awards & highlights
All Individual Drugs Already Approved

Summary

To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous (IV) dose of ETI-204 in adult volunteers.

Eligible Conditions
  • Inhalation Anthrax

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on days 2, 8, 15, 29, 43, and 71.
This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on days 2, 8, 15, 29, 43, and 71. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Who Experienced Adverse Events
Secondary study objectives
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf)
Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last)
Maximum Observed Plasma Concentration of ETI-204 (Cmax)
+6 more

Side effects data

From 2014 Phase 1 trial • 70 Patients • NCT01932242
29%
Somnolence
17%
Dermatitis contact
17%
Upper respiratory tract infection
11%
Infusion site erythema
9%
Infusion site swelling
9%
Headache
6%
Phlebitis superficial
6%
Pruritus
6%
Back pain
6%
Infusion site pain
6%
Dizziness
3%
Diarrhoea
3%
Nausea
3%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sequence A
Sequence B

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ETI-204Experimental Treatment1 Intervention
A single intravenous dose of 16 mg/kg ETI-204 infused over 90 minutes on Day 1
Group II: Placebo for ETI-204Placebo Group1 Intervention
A single intravenous dose of ETI-204-placebo infused over 90 minutes on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obiltoxaximab
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Elusys TherapeuticsLead Sponsor
6 Previous Clinical Trials
399 Total Patients Enrolled
Alex King, MDPrincipal InvestigatorCovance
2 Previous Clinical Trials
116 Total Patients Enrolled
Lori Sieboldt, MDPrincipal InvestigatorCovance Clinical Research - Evansville, IN
~23 spots leftby Dec 2025
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