Pseudomonas Infection Clinical Trial
Official title:
A Randomized, Safety, Tolerability and Pharmacokinetics 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol® in Healthy Subjects
The objective is to determine the safety, tolerability and pharmacokinetics (PK) of 2 single doses of ZTI-01 (1g and 8g infused over 1-hr) and a single dose of the Reference Label Drug, Monurol® (oral sachet, 3g). Subjects will be randomized to a treatment sequence prior to dosing on Day 1 of Period 1 prior to study screening.
This is a Phase 1 single-dose, randomized, 3-Period, crossover study conducted at a single center. A total of 30 healthy subjects, aged 18-45years, will be randomized to receive one of 3 treatment sequences. The duration of study will be approximately 18-26 days and subject participation will be the duration of study. Each treatment sequence will be enrolled in parallel and each subject will receive all 3 treatments in crossover fashion. Each subject will complete Screening, Baseline, and Treatment Phases. The Screening Phase will be conducted on an outpatient basis within 35 days of admission (Day -1 of Period 1). All subjects admitted to the study center the day before dosing in each treatment period (Day -1; check-in) for pre-dosing assessments and will remain in the study center through 48 hours post-dose for each Period. Final baseline qualification will only be evaluated prior to randomization for Treatment Period 1. Each one of the periods will be separated by a 3 (minimum) to 7 days (maximum) washout period. The Treatment Phase will be comprised of 3 crossover periods (duration Day-1 to 48 hours post dose). Each crossover period will include a single dose of study drug under fasting conditions followed by post-dose safety assessments and blood and urine collection for PK measures through 48 hours post-dose; each period will be separated by a 3 to 7 days washout. Subjects will remain in the study center for all 3- study treatment periods (Day -1 to 48 hours post dosing) and will be discharged after the 48-hour sampling timepoint (if safety parameters are acceptable to the Investigator on Day 3). ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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