Inhalational Anthrax Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Dose of ETI-204 in Adult Volunteers
To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous (IV) dose of ETI-204 in adult volunteers.
A double-blind, randomized, placebo-controlled study of a single IV dose of 16 mg/kg ETI-204
in adult volunteers (210 subjects ETI-204; 70 subjects placebo).
The total duration of the study for each subject will be approximately 100 days divided as
follows:
Screening: Days -28 to -2; In-unit Phase: Day -1, Day 1, and Day 2; Out-of-unit Visits: Day 8
(±2 days); Day 15 (±3 days); Day 29 (±3 days); Day 43 (±3 days); Final Visit: Day 71 (±4
days).
Following completion of a screening visit subjects who qualify for entry into the study will
be randomized to receive either ETI-204 or matching placebo on Day 1 in a 3:1 ratio. Subjects
will be discharged from the clinic on Day 2 following completion of study assessments and
will return for five additional visits on Days 8, 15, 29, 43 and 71.
The first 12 subjects will be dosed in groups of no more than 4 subjects/day. A blinded
safety review of the available clinical and laboratory AE data up to and including Day 2 will
be completed for the first 12 subjects before any additional subjects are dosed. This review
will be conducted by the Investigator in conjunction with the Clinical Trial Steering
Committee. If the outcome of this review is satisfactory, dosing of additional subjects will
be permitted to continue and subjects may be dosed in group sizes larger than 4.
After Amendment 1, premedication with 50 mg oral diphenhydramine approximately 30 minutes
prior to the start of study drug infusion was required.
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