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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
G2GBio, Inc.·Phase 1·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Pain, Postoperative
Drug/Device/Intervention
GB-6002
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
G2GBio, Inc.
Location
Seongnam-si, South Korea
Timeline & enrollment
Phase
Phase 1
Start date
Oct 24, 2023
End date
Mar 20, 2024
Enrollment
30 participants
Primary outcome

Adverse Events,Clinical Laboratory tests,Physical examination,Vital signs,Electrocardiograms

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.

ICD-10 classifications
During surgical operationDuring surgical operationDuring surgical operationPain, unspecifiedPostoperative intestinal obstruction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06095973
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06095973 through Pure Global AI's free database. This Phase 1 trial is sponsored by G2GBio, Inc. and is currently Recruiting. The study focuses on Pain, Postoperative. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.