NCT02333318

A Single Ascending Dose Escalation to Investigate Safety and PK of VVZ-149 Injection in Healthy Older Male Volunteers

A Single Ascending Dose Escalation Clinical Trial to Investigate Safety and Pharmacokinetics of VVZ-149 Injection in Healthy Older Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Vivozon, Inc. · Industry
• Sex: Male
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to investigate the safety, tolerability and pharmacokinetics (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older male volunteers.

Detailed description

VVZ-149 injection, an investigational product (IP) in this clinical study, is a multi-target analgesic drug candidate against glycine transporter type II (GlyT2) and serotonin receptor 2A (5HT2A). The target receptors have been known to play important roles in the induction and transmission of pain signals in the pain-related neural system. There have been efforts to develop new drugs that selectively antagonize the GlyT2 or 5HT2A, but it was unsuccessful due to limitations of single-target drugs. VVZ-149 showed morphine-comparable analgesic and gabapentin-comparable anti-allodynic effects in various rat models of pain.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2015-01-07
• Last updated: 2019-03-13