NCT06095973

Dose-Escalation, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GB-6002 Local Infiltration in Healthy Male Adults

A Single Center, Single-blind, Randomized, Dose-escalation, Parallel, Placebo and Active-controlled, Single Dose, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GB-6002 Local Infiltration in Healthy Male Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: G2GBio, Inc. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the safety and tolerability of single dose of GB-6002 (Ropivacaine) Local Infiltration in healthy male Adults. And, It is to compare pharmacokinetic characteristics of GB-6002 single dose injection with active comparator.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	GB-6002	Depending on the cohort, volume will be varied to administer.
DRUG	Placebo	Depending on the cohort, volume will be varied to administer. Volume to be matched with the active investigational drug in the respective cohort.
DRUG	Naropin injection	Single dose of Naropin s.c. injection.

Timeline

• Start date: 2023-10-24
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2023-10-23
• Last updated: 2024-11-18

Locations

1 site across 1 country: South Korea