At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
ETI-204 +1 morebiological
Likely dose
ETI-204 16 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Randomized, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of ETI-204 Alone and in the Presence of Ciprofloxacin in Adult Volunteers
In Brief
A Phase 1 clinical trial evaluating ETI-204 and Ciprofloxacin for Inhalational Anthrax. Completed, enrolled 40 participants across 1 site.
Detailed Summary
Evaluate the safety, tolerability and pharmacokinetics (PK) of intravenous (IV) ETI-204 alone and in the presence of IV and oral ciprofloxacin
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInhalational Anthrax
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartOct 2013
Primary CompletionApr 2014
TodayJul 2026
First PostedSep 30, 2013
Enrollment StartOct 29, 2013
Primary CompletionApr 9, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.8 years ago
Interventions
ETI-204biological
A single IV infusion of 16 mg/kg ETI-204 over 90 minutes on Day 1
Ciprofloxacindrug
A single IV Infusion of 400 mg Ciprofloxacin over 60 minutes immediately following the infusion of ETI-204 on Day 1, followed by oral Ciprofloxacin (750 mg every 12 hours) on Days 2-8, and a final oral dose on the morning of Day 9.