Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers
Condition: Inhalational Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the safety, tolerability and pharmacokinetics (PK) of intravenous (IV) ETI-204 alone
      and in the presence of IV and oral ciprofloxacin
    

Detailed description: 
      An open-label, randomized, parallel group study of IV ETI-204 administered alone and in the
      presence of IV and oral ciprofloxacin in 40 adult volunteers.

      Subjects will be randomized to two groups of 20 subjects each in a 1:1 ratio. Group 1 will
      receive a single IV dose of ETI-204 16 mg/kg followed immediately at the end of the infusion
      by a single dose of IV ciprofloxacin (400 mg), followed by oral ciprofloxacin (750 mg) every
      12 hours on Days 2-8 with the final oral dose on the morning of Day 9. Group 2 will receive
      IV ETI-204 (16 mg/kg) only.

      The total duration of the study for each subject will be approximately 100 days divided as
      follows:Screening: Days -28 to -2; In-Unit Phases: Days -1, 1 and 2 [all subjects]; Days 8, 9
      and 10 [Group 1 only]; Out-of-Unit Visits: Day 9 [Group 2 only]; Day 16 (+/- 3 days); Day 29
      (+/- 3 days); Day 43 (+/- 3 days); Final Visit: Day 71 (+/- 3 days).

      Following completion of a Screening visit subjects will arrive at the clinical research unit
      (CRU) on Day -1 following at least a 10-hour fast. On Day 1, subjects who qualify for entry
      into the study will be randomized to receive either ETI-204 plus IV and oral ciprofloxacin
      (Group 1) or ETI-204 only (Group 2) in a 1:1 ratio according to the randomization treatment
      assignment.

      On Day 1, all subjects will receive 50 mg oral diphenhydramine approximately 30 minutes prior
      to ETI-204 infusion. Subjects in Group 1 will receive IV ETI-204 16 mg/kg infused over 90
      minutes, immediately followed by IV ciprofloxacin 400 mg infused over 60 minutes. Subjects in
      Group 2 will receive IV ETI-204 16 mg/kg infused over 90 minutes.

      All subjects will be discharged from the CRU on Day 2.

      On Days 2 through 8, subjects in Group 1 will receive oral ciprofloxacin (750 mg every 12
      hours); the final dose will be received on the morning of Day 9. Oral ciprofloxacin dosing
      begins 24 hours after the initiation of the ciprofloxacin infusion on Day 1. Subjects in
      Group 1 will return to the CRU on Day 8 and will be discharged from the unit following
      completion of PK sampling on Day 10.

      Subjects in Group 2 will return to the unit for an out-patient visit on Day 9 but will not be
      re-admitted to the CRU for an overnight stay.

      All subjects will return to the CRU for out-patient visits on Days 16, 29, 43, and 71.
    

Intervention name(s): ETI-204; Ciprofloxacin
Intervention type(s): Biological; Drug
Intervention description(s): A single IV infusion of 16 mg/kg ETI-204 over 90 minutes on Day 1; 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.
Other intervention name(s): Obiltoxaximab
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: monoclonal antibody, ETI-204, ciprofloxacin, safety, PK