A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort
study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses
of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will
participate in this study, with the first 9 volunteers in each cohort to qualify being
randomized to receive study medication and the remaining 3 to be used as backups/ alternates.
In each cohort, 6 subjects will be randomly assigned to receive NW-3509A and 3 subjects will
receive placebo.