NCT01905410

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

A Randomized, Double-blind, Single and Multiple Ascending Dose Escalation, Placebo-controlled Clinical Trial to Investigate Safety, Tolerability, and Pharmacokinetics of VVZ-149 Injection in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Vivozon, Inc. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

In this clinical study, the investigational drug product will be offered as an injectable form in a transparent glass vial that contains VVZ-149 dissolved by water for injection. When administered, the drug will be diluted by normal saline and will be given by intravenous infusion for 4 hours. SAD study is planned that maximal 7 cohorts of healthy male subjects are administrated single dose of VVZ-149 injection or placebo. The planned groups for dose escalations were 0.25, 0.5, 1, 2, 4, 6, and 8 mg/kg groups. As a pilot study for safety in this first-in-human study, only 3 subjects received active drug are allocated to first two groups each, without subjects for placebo. For the following groups, 6 subjects for active drug and 2 for placebos are allocated after randomized. MAD study is planned that 2 cohorts of 10 healthy male subjects each were administered multiple doses of VVZ-149 injection or placebo. The final doses of VVZ-149 injection will be determined later based on the results of SAD study. In each group, 7 subjects for active drug and 3 for placebos are allocated after randomized

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	VVZ-149 Injection	VVZ-149 in water for injection
DRUG	placebo	water for injection

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2013-07-23
• Last updated: 2019-03-13

Locations

1 site across 1 country: South Korea