NCT02949089

ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects

An Open Label, Dose Escalation Study of ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study intends to provide information on the safety and tolerability of repeated oral doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to best address the study goals.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	ACH04	The subjects will receive the study medication in each group

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2016-10-31
• Last updated: 2016-10-31

Locations

1 site across 1 country: Brazil