This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The
treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous
(IV) infusion (+10 minute window). A total of 30 enrolled subjects will be randomized to
undergo a single standardized bronchoscopy with bronchoalveolar lavage (BAL) at one of five
sampling times. A total of 6 subjects will be assigned to each BAL-sampling time. Up to ten
additional enrolled subjects will act as alternates to obtain 30 evaluable subjects. An
evaluable subject is defined as a subject who receives all doses of ZTI-01, undergoes BAL at
the randomized sampling timepoint with BAL return volume adequate for testing, and undergoes
at least the one blood sampling timepoint that is concurrent with the assigned BAL sampling
timepoint, with blood sampling volume that is adequate for testing. The objectives of the
study are to assess safety and pharmacokinetics (PK) for a multiple dose regimen of
IV-infused ZTI-01.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)