CompletedNCT06095973Updated Nov 18, 2024

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

A Phase 1 interventional study of GB-6002 and Placebo in Pain, Postoperative, sponsored by G2GBio, Inc.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-18.

Sponsored by G2GBio, Inc. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 19 Years to 55 Years
Sex: Male

Study 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.

Conditions studied

Pain, Postoperative

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Pain, Postoperative 5,093

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 40 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

G2GBio, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 55 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 40 participants (actual)

Study arms

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 · Drug: Placebo · Drug: Naropin 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 · Drug: Placebo · Drug: Naropin 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 · Drug: Placebo · Drug: Naropin 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 · Drug: Placebo · Drug: Naropin injection

Interventions

DrugGB-6002
Depending on the cohort, volume will be varied to administer.
DrugPlacebo
Depending on the cohort, volume will be varied to administer. Volume to be matched with the active investigational drug in the respective cohort.
DrugNaropin injection
Single dose of Naropin s.c. injection.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: Day 1 to Day 14
Physical examination
Incidence of abnormal clinically significant Physical examination results by Study arm.
Time frame: 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.
Time frame: Day 1 to Day 14
Electrocardiograms
Incidence of abnormal clinically significant ECG results by Study arm.
Time frame: Day 1 to Day 14

Secondary outcomes

Pharmacokinetics(Cmax)
Time frame: Day 1 to Day 14
Pharmacokinetics(AUCt)
Time frame: Day 1 to Day 14
Pharmacokinetics(AUCinf)
Time frame: Day 1 to Day 14
Pharmacokinetics(Tmax)
Time frame: Day 1 to Day 14
Pharmacokinetics(t1/2)
Time frame: Day 1 to Day 14
Pharmacokinetics(CL/F)
Time frame: Day 1 to Day 14
Pharmacokinetics(Vz/F)
Time frame: Day 1 to Day 14

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06095973
Lead sponsor: G2GBio, Inc.
Responsible party: Sponsor
First posted: Oct 23, 2023
Start date: Oct 24, 2023
Primary completion: Sep 30, 2024
Completion: Sep 30, 2024
Last update: Nov 18, 2024

Study contacts

Dr. Yoon

principal investigator · Republic of Korea, Seoul National University Bundang Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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