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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: GB-6002; Drug: Placebo; Drug: Naropin injection

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort B; Experimental : GB-6002 for subcutaneous injection at intermediate A dose. Placebo Comparator: Placebo for subcutaneous injection at intermediate intermediate A dose. Active Comparator: Naropin injection(Ropivacaine hydrochloride), single dose.	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.
Other: Cohort C; Experimental : GB-6002 for subcutaneous injection at intermediate B dose. Placebo Comparator: Placebo for subcutaneous injection at intermediate B dose. Active Comparator: Naropin injection(Ropivacaine hydrochloride), single dose.	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.
Other: Cohort D; Experimental : GB-6002 for subcutaneous injection at high dose. Placebo Comparator: Placebo for subcutaneous injection at high dose. Active Comparator: Naropin injection(Ropivacaine hydrochloride), single dose.	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.
Other: Cohort A; Experimental : GB-6002 for subcutaneous injection at low dose. Placebo Comparator: Placebo for subcutaneous injection at low dose. Active Comparator: Naropin injection(Ropivacaine hydrochloride), single dose.	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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: G2GBio, Inc.
• Investigators: Principal Investigator: Dr. Yoon, Republic of Korea, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine
• Other Study ID Numbers: GB6002101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No