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drugset / Trial / NCT02463045

Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis Subjects

NCT02463045 ↗

Phase 1 Completed 67 enrolled Topivert Pharma Ltd
RandomizedSingle-groupTriple-blindTreatment

Summary

This study evaluates the safety and tolerability of TOP1288 rectal single and multiple ascending doses in healthy subjects and multiple doses in subjects with ulcerative colitis.

Timeline

Start
2015-05
Primary completion
2016-07
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject TOP1288 Small molecule 1 mg Rectal
Subject TOP1288 Small molecule 10 mg Rectal
Subject TOP1288 Small molecule 100 mg Rectal
Subject TOP1288 Small molecule 200 mg Rectal
Subject TOP1288 Small molecule 400 mg Rectal

Indications

ulcerative colitis