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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: GB-6002
* Drug: Placebo
* Drug: Naropin injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult males,19 to 55 years of age, inclusive at the time of screening visit. At the time of screening, those with a body weight of 55 kg or more and a BMI (Body Mass Index) within 18.0 to 27.0 kg/m², inclusive. Subjects who do not have plans to receive COVID-19(coronavirus disease 2019) vaccination during the clinical trial starting from 14 days prior to the first administration of investigational drug. Subjects who have understood the purpose of this clinical trial, voluntarily chosen to participate, and provided written consent to adhere to the restrictions. Exclusion Criteria: Subjects with clinically significant cardiovascular, respiratory, hepatic, renal, neurological, endocrine, hematologic, oncological, psychiatric, or urological conditions, or a history related to such conditions. Subjects with systolic blood pressure less than 90 mmHg or greater than 150 mmHg, or diastolic blood pressure less than 50 mmHg or greater than 100 mmHg during the screening assessments. Subjects who exhibited clinically significant abnormalities in physical examination, clinical laboratory tests, or electrocardiograms during the screening assessments. Subjects known to be hypersensitive to Investigational Product and its components. Subjects who have continued to drink alcohol within 1 month prior to the first administration of Investigational Product or who are unable to abstain from alcohol during the clinical trial. Subjects who smoked continuously within 1 month prior to the first administration of Investigational Product or are unable to quit smoking during the clinical trial. Subjects who has taken drugs that induce or inhibit drug metabolism enzymes, such as barbiturates, within 1 month prior to the first administration of Investigational Product.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: sequential
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GB-6002<br>GB-6002 for subcutaneous (SC) injection at three doses(low, intermediate, high) | Drug: GB-6002<br>* Depending on the cohort, volume will be varied to administer.<br>|
| Placebo Comparator: Placebo<br>Placebo for subcutaneous (SC) injection at three doses(low, intermediate, high) | Drug: Placebo<br>* Depending on the cohort, volume will be varied to administer. Volume to be matched with the active investigational drug in the respective cohort.<br>|
| Active Comparator: Naropin injection(Ropivacaine hydrochloride)<br>Naropin injection(Ropivacaine hydrochloride), single dose | Drug: Naropin injection<br>* Single dose of Naropin s.c. injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | 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. | Day 1 to Day 14 | 
| Clinical Laboratory tests | 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. | Day 1 to Day 14 | 
| Physical examination | Incidence of abnormal clinically significant Physical examination results by Study arm. | Day 1 to Day 14 | 
| Vital signs | Incidence of abnormal clinically significant vital signs(Systolic and Diastolic Blood Pressure, Pulse Rate, Body Temperature) results by Study arm. | Day 1 to Day 14 | 
| Electrocardiograms | Incidence of abnormal clinically significant ECG results by Study arm. | Day 1 to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics(Cmax) |  | Day 1 to Day 14 | 
| Pharmacokinetics(AUCt) |  | Day 1 to Day 14 | 
| Pharmacokinetics(AUCinf) |  | Day 1 to Day 14 | 
| Pharmacokinetics(Tmax) |  | Day 1 to Day 14 | 
| Pharmacokinetics(t1/2) |  | Day 1 to Day 14 | 
| Pharmacokinetics(CL/F) |  | Day 1 to Day 14 | 
| Pharmacokinetics(Vz/F) |  | Day 1 to Day 14 |