drugset / Trial / NCT01757795

Safety, Tolerability and Pharmacokinetics of SP-8203

NCT01757795 ↗

Phase 1 Completed 72 enrolled Shin Poong Pharmaceutical Co. Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

Phase I study in health volunteers to assess the safety, tolerability and pharmacokinetics of escalating single doses and multiple doses of SP-8203

Timeline

Start
2013-12-23
Primary completion
2015-03-11
Completion
2015-03-11

Drugs

EvaluationDrugModalityDoseRoute
Subject OTAPLIMASTAT Small molecule 10 mg Intravenous
Subject OTAPLIMASTAT Small molecule 20 mg Intravenous
Subject OTAPLIMASTAT Small molecule 40 mg Intravenous
Subject OTAPLIMASTAT Small molecule 80 mg Intravenous
Subject OTAPLIMASTAT Small molecule 160 mg Intravenous
Subject OTAPLIMASTAT Small molecule 240 mg Intravenous

Indications