NCT03291418

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Antibe Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Gastric Ulcer

Interventions

Type	Name	Description
DRUG	ATB-346 OR Placebo	Comparison of gastrointestinal effects
DRUG	Naproxen sodium	Comparison of gastrointestinal effects

Timeline

• Start date: 2017-09-08
• Primary completion: 2018-03-31
• Completion: 2018-04-30
• First posted: 2017-09-25
• Last updated: 2018-06-06

Locations

1 site across 1 country: Canada