Study to Assess Safety, Tolerability and Pharmacokinetics of Treamid in Healthy Volunteers

Summary

A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and tolerability of increasing doses of Treamid after single and repeated oral administration in healthy volunteers. The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break. The primary objective of the study was to evaluate the safety and tolerability profile of Treamid after single and multiple administration based on the frequency and severity of adverse events and changes in vital signs, laboratory results, electrocardiography and results of the physical examination. The secondary objective of the study was to assess pharmacokinetics of active pharmaceutical substance of Treamid.

Timeline

Start

2016-01-25

Primary completion

2016-11-21

Completion

2016-11-21

Drugs

Indications