NCT02522598

Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following Gastrectomy

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following Laparoscopic-assisted Gastrectomy in Early Gastric Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Vivozon, Inc. · Industry
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity inhibiting GlyT2 and 5HT2A simultaneously. These target receptors have been known to play important roles in induction and transmission of pain signals. There have been many efforts to develop 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 be a dual-target drug, demonstrated having a potential synergism between GlyT2 and 5HT2A to maximize an antinociceptive effect in the in vivo animal models. In Phase 1 conducted among healthy subjects, safety and tolerability were confirmed. Phase 2 was designed as a randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy and safety of the analgesic drug VVZ-149 injection.

Detailed description

VVZ-149 is a dual antagonist of GlyT2 and 5HT2A. GlyT2 blockage increases inhibitory synaptic transmission by glycine in the spinal cord, resulting in a reduction of pain transmissions to the brain. 5HT2A blockage decreases descending serotonergic facilitatory modulation on pain transmission by the brain and reduces nociceptor activation in peripheral nerves, which are primary sources of pain in post-surgical pain. VVZ-149 has been shown to have comparable efficacy to morphine in well controlled (blind, complete randomization with a positive control) animal studies using rat models of post-operative pain and formalin-induced pain. The PK/PD study in animals indicates that therapeutic plasma concentration in human subjects will be 600-1,900 ng/ml. A clinical Phase 1 study performed in healthy subjects has shown no clinically significant adverse events up to a plasma concentration level of 3,261 ng/ml other than brief symptoms of mild nausea or dizziness, and mild somnolence when the plasma exposure level is more than 2,000 ng/ml.

Conditions

• Post-Operative Pain

Interventions

Type	Name	Description
DRUG	VVZ-149 injections	Colorless, transparent liquid in water for injection
DRUG	Placebo	water for injection

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-08-13
• Last updated: 2016-09-29

Locations

1 site across 1 country: South Korea