Seoul National University Bundang Hospital
Seongnam-si, South Korea
NCT Number: NCT06095973
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.
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Notify Me19 year–55 year
Male
Interventional
Phase 1
Seongnam-si, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Depending on the cohort, volume will be varied to administer.
Depending on the cohort, volume will be varied to administer. Volume to be matched with the active investigational drug in the respective cohort.
Single dose of Naropin s.c. injection.
Time frame: Day 1 to Day 14
Number of subjects and Incidences with adverse events by Study arm. Number of subjects and Incidences with Injection site assessments for nodules by Study arm.
Time frame: Day 1 to Day 14
Incidence of abnormal clinically significant clinical laboratory test results (Hematology, Blood Chemistry Test, Urine Test, Blood Coagulation Test, Serum Test and Urine Drug Screening Test, etc) by study arm.
Time frame: Day 1 to Day 14
Incidence of abnormal clinically significant Physical examination results by Study arm.
Time frame: Day 1 to Day 14
Incidence of abnormal clinically significant vital signs(Systolic and Diastolic Blood Pressure, Pulse Rate, Body Temperature) results by Study arm.
Time frame: Day 1 to Day 14
Incidence of abnormal clinically significant ECG results by Study arm.
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
G2GBio, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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