Dose-Escalation, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GB-6002 Local Infiltration in Healthy Male Adults - Trial NCT06095973

Name: Clinical Trial NCT06095973
Creator: G2GBio, Inc.
Keywords: Pain, Postoperative, GB-6002, Phase 1, drug, clinical trial, South Korea

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.

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NCT06095973

Phase 1

Recruiting

drug

Trial Details

ClinicalTrials.gov • NCT06095973

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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

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 operation

Pain, unspecified

Postoperative intestinal obstruction

Data Source

Registry

ClinicalTrials.gov

Trial ID

NCT06095973

Type

Non-Device Trial