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 (P1_VVZ149IV)

NCT01905410 Phase 1 COMPLETED

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.

Details

Lead sponsor	Vivozon, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	66
Start date	2013-07
Completion	2014-04

Conditions

• Healthy

Interventions

• VVZ-149 Injection
• placebo

Primary outcomes

• Assessment of Adverse Events Appearance According to the NCI CTCAE V 4.02 — upto 8 days (SAD) / 13 days (MAD)
  According to the NCI CTCAE V 4.02, DLT (Dose Limiting Toxicity) is defined when it is applicable at least one criterion among following items * adverse event over CTCAE Grade 3 * Any other significant toxicity according to the investigator's judgment Safety and Tolerability Measurements : physical examination, vital signs, 12-lead ECG, consecutive ECG and SpO2 monitoring, clinical laboratory tests(hematology, clinical chemistry, liver function, thyroid function, coagulation, urine analysis)

Countries

South Korea