A Study of Fosmanogepix in Healthy Adult Chinese Subjects
brief summary
The purpose of this study was to investigate the pharmacokinetics and safety of the investigational drug fosmanogepix including its active moiety manogepix following a single dose and multiple doses (by intravenous infusion (IV) or orally) in healthy Chinese adults. The study consisted of 2 consecutive Parts (Part-1, single-dose part followed by Part-2, multiple-dose part) including a total of 54 subjects (32 subjects in Part-1 and 22 subjects in PART-2) randomized.
detailed description
Part-1 duration including screening period was up to 64 days including 4 visits at the clinical site and Part-2 duration including screening period was up to 70 days including 5 visits at the clinical site. The study included a total of 4 study sub-groups (Cohorts 1-4) in which fosmanogepix or placebo was administered in different strengths orally or IV.
Subjects were enrolled and randomly assigned to study drug.
During the study, serial blood samples were collected to understand how fosmanogepix was changed and eliminated from the body.
The primary objective of PART-1 (Single-dose) was to evaluate the pharmacokinetic (PK) profile of manogepix (active moiety of fosmanogepix) after single dose administration in healthy adult Chinese subjects.
The primary objective of PART-2 (Multiple-dose) was to evaluate the PK profile of manogepix (active moiety of fosmanogepix) after repeated doses in healthy adult Chinese subjects.
All data analyses are descriptive (no statistical analysis is provided).
official title
A Phase 1, Randomized, Single-center, Double-blind, Placebo-controlled Study of Fosmanogepix Administered as Single and Multiple Doses in Healthy Adult Chinese Subjects