drugset
drugset / Trial / NCT01905410

Phase I Study to Investigate Safety, Tolerability, and Pharmacokinetics of VVZ-149 Injection

NCT01905410 ↗

Phase 1 Completed 66 enrolled Vivozon, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity inhibiting GlyT2 and 5HT2A simultaneously. There have been many efforts to develop single-target selective drugs to treat pain, but usually unsuccessful due to the lack of efficacy or limitations of single-target approach for new drug discovery. VVZ-149 is expected to have a dual-target activity, demonstrated having a synergism between GlyT2 and 5HT2A antagonistic activities to maximize an antinociceptive effect in the in vivo animal models. Now the investigators are developing VVZ-149 as an IV injection to treat post-operative pain. The primary objective of this study is to evaluate a safety, tolerability and pharmacokinetic properties of VVZ-149 injection with placebo in healthy male volunteers. This Phase 1 study consists of a randomized, double-blind, placebo controlled, single and multiple ascending dose (SAD \& MAD) escalation clinical trials.

Timeline

Start
2013-07
Primary completion
2014-03
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject VVZ-149 Small molecule 0.25 mg/kg Intravenous
Subject VVZ-149 Small molecule 0.5 mg/kg Intravenous
Subject VVZ-149 Small molecule 1 mg/kg Intravenous
Subject VVZ-149 Small molecule 2 mg/kg Intravenous
Subject VVZ-149 Small molecule 4 mg/kg Intravenous
Subject VVZ-149 Small molecule 6 mg/kg Intravenous
Subject VVZ-149 Small molecule 8 mg/kg Intravenous

Indications

No indication recorded.