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

NCT06095973 | Completed Phase 1

• 1 other identifier: GB6002101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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

Study Arms (4)

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.

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.

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.

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.

Drug: GB-6002; Drug: Placebo; Drug: Naropin injection

Interventions

GB-6002 DRUG

Depending on the cohort, volume will be varied to administer.

Cohort A; Cohort B; Cohort C; Cohort D

Placebo DRUG

Depending on the cohort, volume will be varied to administer. Volume to be matched with the active investigational drug in the respective cohort.

Cohort A; Cohort B; Cohort C; Cohort D

Naropin injection DRUG

Single dose of Naropin s.c. injection.

Cohort A; Cohort B; Cohort C; Cohort D

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• G2GBio, Inc.: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Dr. Yoon

  Republic of Korea, Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: sequential

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 23, 2023
• Study Start: October 24, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

KR (1)