NCT01505907

Pharmacokinetic Study of CXB909 in Healthy Male Subjects

Phase I, Randomized, Double-Blind, Placebo Controlled, Dose Escalation,Single Dose, Safety, Tolerance, and Pharmacokinetic Study of CXB909 in Healthy Male Volunteers

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: CeNeRx BioPharma Inc. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this dose escalation study is to examine the safety, tolerability, and pharmacokinetic properties of single-doses of CXB909, compared to placebo, in healthy male volunteers. This study may evaluate five (5) dose levels of CXB909; however, the number of dose levels, as well as the dosages, may be adjusted after evaluation of in-study analysis of the safety, tolerability, and pharmacokinetic data. This study will attempt to identify the maximum tolerated single dose of CXB909.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CXB909	CXB909

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2012-01-09
• Last updated: 2012-01-09