Pain, PostoperativePhase 1NCT06095973
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 study testing GB-6002 and Naropin injection in people with Pain, Postoperative, run by G2GBio, Inc. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- GB-6002 and Naropin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Oct 2023to 30 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Pain, Postoperative
- Being tested
- GB-6002, Placebo, Naropin injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB-6002Drug
Depending on the cohort, volume will be varied to administer.
PlaceboDrug
Depending on the cohort, volume will be varied to administer. Volume to be matched with the active investigational drug in the respective cohort.
Naropin injectionDrug
Single dose of Naropin s.c. injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort B | Other | 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. Receives: Drug: GB-6002; Drug: Placebo; Drug: Naropin injection |
| Cohort C | Other | 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. Receives: Drug: GB-6002; Drug: Placebo; Drug: Naropin injection |
| Cohort D | Other | 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. Receives: Drug: GB-6002; Drug: Placebo; Drug: Naropin injection |
| Cohort A | Other | 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. Receives: Drug: GB-6002; Drug: Placebo; Drug: Naropin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1 to Day 14
Physical examination
Incidence of abnormal clinically significant Physical examination results by Study arm.
Measured: 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.
Measured: Day 1 to Day 14
Electrocardiograms
Incidence of abnormal clinically significant ECG results by Study arm.
Measured: Day 1 to Day 14
Secondary outcomes (7)
Pharmacokinetics(Cmax)
Measured: Day 1 to Day 14
Pharmacokinetics(AUCt)
Measured: Day 1 to Day 14
Pharmacokinetics(AUCinf)
Measured: Day 1 to Day 14
Pharmacokinetics(Tmax)
Measured: Day 1 to Day 14
Pharmacokinetics(t1/2)
Measured: Day 1 to Day 14
Pharmacokinetics(CL/F)
Measured: Day 1 to Day 14
Pharmacokinetics(Vz/F)
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start24 Oct 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- G2GBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Yoon, Principal investigator, Republic of Korea, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095973
- Sponsor's protocol ID
- GB6002101
- Status last verified
- Nov 2024
- First submitted
- 4 Oct 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06095973
- Acronym / sponsor ID
- GB6002101
- Conditions
- Pain, Postoperative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- G2GBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- sequential
| Arm | Type | Receives |
|---|---|---|
| Cohort B | Other | Drug: GB-6002, Drug: Placebo, Drug: Naropin injectionExperimental : 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. |
| Cohort C | Other | Drug: GB-6002, Drug: Placebo, Drug: Naropin injectionExperimental : 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. |
| Cohort D | Other | Drug: GB-6002, Drug: Placebo, Drug: Naropin injectionExperimental : 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. |
| Cohort A | Other | Drug: GB-6002, Drug: Placebo, Drug: Naropin injectionExperimental : 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. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB-6002Depending on the cohort, volume will be varied to administer. | Drug | Cohort A, Cohort B, Cohort C, Cohort D |
| PlaceboDepending on the cohort, volume will be varied to administer. Volume to be matched with the active investigational drug in the respective cohort. | Drug | Cohort A, Cohort B, Cohort C, Cohort D |
| Naropin injectionSingle dose of Naropin s.c. injection. | Drug | Cohort A, Cohort B, Cohort C, Cohort D |
Primary outcome
Adverse Events
Time frame: Day 1 to Day 14
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
Time frame: Day 1 to Day 14
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
Time frame: Day 1 to Day 14
Incidence of abnormal clinically significant Physical examination results by Study arm.
Vital signs
Time frame: Day 1 to Day 14
Incidence of abnormal clinically significant vital signs(Systolic and Diastolic Blood Pressure, Pulse Rate, Body Temperature) results by Study arm.
Electrocardiograms
Time frame: Day 1 to Day 14
Incidence of abnormal clinically significant ECG results by Study arm.
7 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Yoon principal investigator
Republic of Korea, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB-6002 and Naropin injection in people with Pain, Postoperative, run by G2GBio, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Day 1 to Day 14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.