Overview

Phase I Trial of a Single Dose of CRS3123

Status:
Completed
Trial end date:
2014-04-21
Target enrollment:
Participant gender:
Summary
Double-blind, randomized, placebo-controlled Phase I Trial to determine the safety and pharmokinetics of a single dose of CRS3123 in healthy adult volunteers. Forty healthy male and female subjects 18 to 45 years will be admitted in 5 dosing Cohorts, 8 subjects per Cohort. Up to two alternates may be used per dosing Cohorts for study subjects that drop out. The primary objective of the study is to determine the safety and tolerability of escalating doses of CRS3123 following oral administration to healthy subjects.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)