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To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects

Gastric Ulcer Clinical Trial

Official title:
A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects

Clinical Trial Summary

A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects

Clinical Trial Description

Healthy male and female subjects (n=240) are randomized into two dose groups of 120 subjects each. Gastroduodenal endoscopies are performed pre-dose and post-dose, i.e., after 14 days of either ATB-346 (250 mg once daily) or naproxen sodium (550 mg twice daily) and the incidence of gastric mucosal damage is recorded for comparison between the two treatment arms. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03291418
Study type Interventional
Source Antibe Therapeutics Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 8, 2017
Completion date April 30, 2018
View Details
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