Inhalational Anthrax Clinical Trial
Official title:
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
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
Following completion of a Screening visit subjects will arrive at the clinic on Day -1. On
Day 1, subjects will be randomized in a 3:1 ratio to receive an IM dose of either ETI-204 or
matching placebo, respectively:
Cohort 1: 4 subjects randomized to 4 mg/kg ETI-204 or matching placebo Cohort 2: 8 subjects
randomized to 8 mg/kg ETI-204 or matching placebo Cohort 3: 8 subjects randomized to 16 mg/kg
ETI-204 or matching placebo Cohort 4: 8 subjects randomized to 20 mg/kg ETI-204 or matching
placebo Cohort 5: 8 subjects randomized to 24 mg/kg ETI-204 or matching placebo
Study drug will be injected bilaterally into the vastus lateralis muscles, with the subject
in a supine position. A separate syringe with a 21-gauge,1.5-inch needle will be used for
each injection. The number of injections and injection volume will increase with increasing
dose allowing for an assessment of increasing IM ETI-204 doses and the tolerability of a
larger number of injections and larger injection volume.
Subjects will be pretreated with 50 mg oral diphenhydramine approximately 30 minutes prior to
administration of study drug.
Subjects will be discharged from the study facility on Day 4 following completion of study
assessments and will return to the study facility for additional visits on Days 7, 10, 15 (±3
days), 29 (±3 days), 43 (±3 days), and 71 (±4 days).
Decisions to dose-escalate will be made by the investigator(s) in conjunction with the
sponsor and will be based solely on the available safety and local tolerability data up to
and including Day 4.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01952444 -
Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers
|
Phase 1 | |
| Completed |
NCT01929226 -
Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers
|
Phase 1 | |
| Completed |
NCT01932242 -
Safety, Tolerability and PK of Repeat Administration of Intravenous ETI-204 in Adult Volunteers
|
Phase 1 | |
| Not yet recruiting |
NCT03569553 -
A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients
|