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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095973
• Other study ID #: GB6002101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 24, 2023
• Est. completion date: March 20, 2024

Study information

• Verified date: October 2023
• Source: G2GBio, Inc.
• Contact: Jimin Hwang
• Phone: 82-2-400-2681
• Email: clinicalstudy[@]g2gbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 20, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• GB-6002
Depending on the cohort, volume will be varied to administer.
• Placebo
Depending on the cohort, volume will be varied to administer. Volume to be matched with the active investigational drug in the respective cohort.
• Naropin injection
Single dose of Naropin s.c. injection.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si

Sponsors (1)

Lead Sponsor	Collaborator
G2GBio, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Physical examination	Incidence of abnormal clinically significant Physical examination results by Study arm.	Day 1 to Day 14
Primary	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
Primary	Electrocardiograms	Incidence of abnormal clinically significant ECG results by Study arm.	Day 1 to Day 14
Secondary	Pharmacokinetics(Cmax)		Day 1 to Day 14
Secondary	Pharmacokinetics(AUCt)		Day 1 to Day 14
Secondary	Pharmacokinetics(AUCinf)		Day 1 to Day 14
Secondary	Pharmacokinetics(Tmax)		Day 1 to Day 14
Secondary	Pharmacokinetics(t1/2)		Day 1 to Day 14
Secondary	Pharmacokinetics(CL/F)		Day 1 to Day 14
Secondary	Pharmacokinetics(Vz/F)		Day 1 to Day 14