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Completed

NCT Number: NCT06095973

Dose-Escalation, Single Dose Study 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.

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Key information

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GB-6002

Drug

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

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.

Naropin injection

Drug

Single dose of Naropin s.c. injection.

Primary outcomes

  1. 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.

  2. 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.

  3. Physical examination

    Time frame: Day 1 to Day 14

    Incidence of abnormal clinically significant Physical examination results by Study arm.

  4. 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.

  5. Electrocardiograms

    Time frame: Day 1 to Day 14

    Incidence of abnormal clinically significant ECG results by Study arm.

Secondary outcomes

  1. Pharmacokinetics(Cmax)

    Time frame: Day 1 to Day 14

  2. Pharmacokinetics(AUCt)

    Time frame: Day 1 to Day 14

  3. Pharmacokinetics(AUCinf)

    Time frame: Day 1 to Day 14

  4. Pharmacokinetics(Tmax)

    Time frame: Day 1 to Day 14

  5. Pharmacokinetics(t1/2)

    Time frame: Day 1 to Day 14

  6. Pharmacokinetics(CL/F)

    Time frame: Day 1 to Day 14

  7. Pharmacokinetics(Vz/F)

    Time frame: Day 1 to Day 14

Sponsors and collaborators

Lead sponsor

G2GBio, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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