drugset
drugset / Trial / NCT02415439

A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects

NCT02415439 ↗

Phase 1 Completed 86 enrolled ReveraGen BioPharma, Inc.
RandomizedSingle-groupQuadruple-blindTreatment

Summary

The purpose of this study is to examine the safety, tolerability, and PK of various increasing single and multiple doses of VBP15 in healthy adult subjects.

Timeline

Start
2015-01
Primary completion
2015-11
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Vamorolone Small molecule 0.1 mg/kg Oral
Subject Vamorolone Small molecule 0.3 mg/kg Oral
Subject Vamorolone Small molecule 1 mg/kg Oral
Subject Vamorolone Small molecule 3 mg/kg Oral
Subject Vamorolone Small molecule 8 mg/kg Oral
Subject Vamorolone Small molecule 9 mg/kg Oral
Subject Vamorolone Small molecule 20 mg/kg Oral

Indications

No indication recorded.