A Phase I, open label study of a single dose of 30 mg/kg of apramycin administered
intravenously (IV) over 30 (+/- 5) minutes. Twenty subjects will be enrolled in the study to
one of 5 cohorts, T1-T5, each corresponding to a timepoint after initiation of infusion at
which a single fiberoptic bronchoscopy with bronchoalveolar lavage (BAL) is performed. There
will be 4 subjects per cohort. Cohort T5 will be enrolled after plasma and lung apramycin
concentrations and preliminary PK data analysis are completed in cohorts T1-T4. Enrollment
and dosing will be determined by bronchoscopy schedule. For each cohort, if 2 subjects are
scheduled to receive study drug on the same day, the dose will be administered sequentially
at least 2 hours apart. The primary objective is to assess plasma pharmacokinetic (PK)
profile of apramycin and lung penetration of apramycin in epithelial lining fluid (ELF) and
alveolar macrophages (AM) after single intravenous (IV) apramycin dose of 30 mg/kg in healthy
subjects.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)