Clinical trial NCT06095973: Dose-Escalation, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GB-6002 Local Infiltration in Healthy Male Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain, Postoperative
Lead sponsor: G2GBio, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: sequential
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events
timeFrame: Day 1 to Day 14
measure: Clinical Laboratory tests
timeFrame: Day 1 to Day 14
measure: Physical examination
timeFrame: Day 1 to Day 14
measure: Vital signs
timeFrame: Day 1 to Day 14
measure: Electrocardiograms
timeFrame: Day 1 to Day 14
Secondary outcomes:
measure: Pharmacokinetics(Cmax)
timeFrame: Day 1 to Day 14
measure: Pharmacokinetics(AUCt)
timeFrame: Day 1 to Day 14
measure: Pharmacokinetics(AUCinf)
timeFrame: Day 1 to Day 14
measure: Pharmacokinetics(Tmax)
timeFrame: Day 1 to Day 14
measure: Pharmacokinetics(t1/2)
timeFrame: Day 1 to Day 14
measure: Pharmacokinetics(CL/F)
timeFrame: Day 1 to Day 14
measure: Pharmacokinetics(Vz/F)
timeFrame: Day 1 to Day 14
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Republic of Korea, Seoul National University Bundang Hospital
name: Dr. Yoon
role: PRINCIPAL_INVESTIGATOR
References: