MedTrace Logo

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

NCT06095973 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • G2GBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Yoon · Republic of Korea, Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-24
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06095973 on ClinicalTrials.gov