NCT01990885

Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.

A Two-Part, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Systemic Exposure of Single Escalating Administrations and Repeated Administration of BL-7010 in Well-Controlled Celiac Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: BioLineRx, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of different amounts of BL-7010 in single oral administration and in repeated oral administration to well-controlled celiac patients. Another purpose is to evaluate if BL-7010 is absorbed by the body or not.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	BL-7010
DRUG	Placebo

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-11-25
• Last updated: 2017-08-18

Locations

2 sites across 1 country: Finland