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

G2GBio

Status and phase: Completed; Phase 1

Conditions: Pain, Postoperative

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06095973

GB6002101

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

Cohort B

Other group

Description:

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.

Treatment:

Drug: Placebo

Drug: Naropin injection

Drug: GB-6002

Cohort C

Other group

Description:

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.

Treatment:

Drug: Placebo

Drug: Naropin injection

Drug: GB-6002

Cohort D

Other group

Description:

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.

Treatment:

Drug: Placebo

Drug: Naropin injection

Drug: GB-6002

Cohort A

Other group

Description:

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.

Treatment:

Drug: Placebo

Drug: Naropin injection

Drug: GB-6002