Status:
COMPLETED
Dose-Escalation, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GB-6002 Local Infiltration in Healthy Male Adults
Lead Sponsor:
G2GBio, Inc.
Conditions:
Pain, Postoperative
Eligibility:
MALE
19-55 years
Phase:
PHASE1
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-600...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06095973
Start Date
October 24 2023
End Date
September 30 2024
Last Update
November 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Bundang Hospital
Seongnam-si, South Korea