PK Study of Single-Dose ZTI-01 in Children (<12 Years of Age)
brief summary
Phase 1 study, a single dose of ZTI-01 given to pediatric subjects (under 12 years of age) who require antibiotic therapy to see what the body does to the drug (pharmacokinetics) and to compare if these effects are similar to those observed in adults at a 6g ZTI-01 dose. Study will help establish pediatric dosing in younger children by age cohort. This is a multiple-center, open-label, PK study of ZTI-01 (fosfomycin for injection) single dose scaled by allometric weight-modeling from an adult ZTI-01 dose of 6 grams. Eligible subjects must be receiving standard of care antibiotics for proven or suspected bacterial infection or for peri-operative prophylaxis surgery (in or out of hospital).
detailed description
Based on pre-dose weight on Day -1, subjects weighing within the 3rd to \< 97th percentile based on age - will receive a single, weight adjusted dose of ZTI-01 via continuous IV infusion or syringe pump over a 1- hour (+10 min) period. Pediatric subjects participating in this study will be assigned to one of three cohorts based on age:
Cohort 1: ≥ 6 years to \<12 years (n=6 PK evaluable subjects) Cohort 2: ≥ 2 years to \<6 years (n=6 PK evaluable subjects)
Cohort 3: Birth to \< 2 years (n=9 PK evaluable subjects), split into 3 subgroups:
(3a) Birth (defined as full term: 37 weeks of gestations or greater) to \< 3 mos, (3b) ≥ 3 mos to \< 6 mos, (3c) ≥ 6 mos to \< 24 months
Cohorts 1 and 2 will be enrolled first with safety and PK data evaluated before enrolling the youngest Cohort 3. Blood for fosfomycin concentration measurement will be collected throughout the study. Safety will be assessed by monitoring adverse and serious adverse events based on medical history, vital signs, ECG, laboratory assessment and physical examination.
official title
Phase 1, Non-comparative, Open-Label Study of Pharmacokinetics and Safety of a Single-Dose of ZTI-01 (Fosfomycin for Injection) in Pediatric Subjects (<12 Years of Age)