NCT03220633

Study To Assess Safety, Tolerability And PK Of ATB-346 In Healthy Subjects

A Double-Blind, Placebo-Controlled, Phase I Study To Assess Safety, Tolerability And Pharmacokinetics Of Single/Multiple Ascending Doses Of ATB-346 Orally Administrated In Healthy Male And Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Antibe Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A double-blind, placebo-controlled, phase I study to assess safety, tolerability and pharmacokinetics of single/multiple ascending doses of atb-346 orally administered in healthy male and female subjects.

Detailed description

Single ascending doses of ATB-346 given to multiple cohorts followed by multiple ascending doses of ATB-346 given to multiple cohorts in order to assess its safety, tolerability, and pharmacokinetics. A single dose cohort was also conducted to assess the effect of food on the drug's characteristics.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	ATB-346
DRUG	Placebo

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2017-07-18
• Last updated: 2017-07-18

Locations

1 site across 1 country: Canada