At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
ETI-204 +1 morebiological
Likely dose
Not stated in 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.
A Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Intramuscular Doses of ETI-204 in Adult Volunteers
In Brief
A Phase 1 clinical trial evaluating ETI-204 and Placebo for Inhalational Anthrax. Completed, enrolled 36 participants across 1 site.
Detailed Summary
This study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInhalational Anthrax
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedAug 2013
Primary CompletionJul 2014
TodayJul 2026
First PostedAug 30, 2013
Enrollment StartJul 26, 2013
Primary CompletionJul 3, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.8 years ago
Interventions
ETI-204biological
monoclonal antibody
Placeboother
Placebo for ETI-204