search
Back to results

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

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GB-6002
Placebo
Naropin injection
Sponsored by
G2GBio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

19 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

GB-6002

Placebo

Naropin injection(Ropivacaine hydrochloride)

Arm Description

GB-6002 for subcutaneous (SC) injection at three doses(low, intermediate, high)

Placebo for subcutaneous (SC) injection at three doses(low, intermediate, high)

Naropin injection(Ropivacaine hydrochloride), single dose

Outcomes

Primary Outcome Measures

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.
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.
Physical examination
Incidence of abnormal clinically significant Physical examination results by Study arm.
Vital signs
Incidence of abnormal clinically significant vital signs(Systolic and Diastolic Blood Pressure, Pulse Rate, Body Temperature) results by Study arm.
Electrocardiograms
Incidence of abnormal clinically significant ECG results by Study arm.

Secondary Outcome Measures

Pharmacokinetics(Cmax)
Pharmacokinetics(AUCt)
Pharmacokinetics(AUCinf)
Pharmacokinetics(Tmax)
Pharmacokinetics(t1/2)
Pharmacokinetics(CL/F)
Pharmacokinetics(Vz/F)

Full Information

First Posted
October 4, 2023
Last Updated
October 17, 2023
Sponsor
G2GBio, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT06095973
Brief Title
Dose-Escalation, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GB-6002 Local Infiltration in Healthy Male Adults
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2023 (Actual)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
G2GBio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
sequential
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GB-6002
Arm Type
Experimental
Arm Description
GB-6002 for subcutaneous (SC) injection at three doses(low, intermediate, high)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for subcutaneous (SC) injection at three doses(low, intermediate, high)
Arm Title
Naropin injection(Ropivacaine hydrochloride)
Arm Type
Active Comparator
Arm Description
Naropin injection(Ropivacaine hydrochloride), single dose
Intervention Type
Drug
Intervention Name(s)
GB-6002
Intervention Description
Depending on the cohort, volume will be varied to administer.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Depending on the cohort, volume will be varied to administer. Volume to be matched with the active investigational drug in the respective cohort.
Intervention Type
Drug
Intervention Name(s)
Naropin injection
Intervention Description
Single dose of Naropin s.c. injection.
Primary Outcome Measure Information:
Title
Adverse Events
Description
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
Title
Clinical Laboratory tests
Description
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
Title
Physical examination
Description
Incidence of abnormal clinically significant Physical examination results by Study arm.
Time Frame
Day 1 to Day 14
Title
Vital signs
Description
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
Title
Electrocardiograms
Description
Incidence of abnormal clinically significant ECG results by Study arm.
Time Frame
Day 1 to Day 14
Secondary Outcome Measure Information:
Title
Pharmacokinetics(Cmax)
Time Frame
Day 1 to Day 14
Title
Pharmacokinetics(AUCt)
Time Frame
Day 1 to Day 14
Title
Pharmacokinetics(AUCinf)
Time Frame
Day 1 to Day 14
Title
Pharmacokinetics(Tmax)
Time Frame
Day 1 to Day 14
Title
Pharmacokinetics(t1/2)
Time Frame
Day 1 to Day 14
Title
Pharmacokinetics(CL/F)
Time Frame
Day 1 to Day 14
Title
Pharmacokinetics(Vz/F)
Time Frame
Day 1 to Day 14

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Na-Yeon Park
Phone
82-2-400-2694
Email
clinicalstudy@g2gbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shin-Won Lee
Phone
82-2-6956-2698
Email
clinicalstudy@g2gbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Yoon
Organizational Affiliation
Republic of Korea, Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs