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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- G2GBio, Inc.
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Vital signs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort B
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.
干预措施: GB-6002 (Drug)
Cohort B
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.
干预措施: Placebo (Drug)
Cohort B
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.
干预措施: Naropin injection (Drug)
Cohort C
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.
干预措施: GB-6002 (Drug)
Cohort C
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.
干预措施: Placebo (Drug)
Cohort C
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.
干预措施: Naropin injection (Drug)
Cohort D
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.
干预措施: GB-6002 (Drug)
Cohort D
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.
干预措施: Placebo (Drug)
Cohort D
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.
干预措施: Naropin injection (Drug)
Cohort A
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.
干预措施: GB-6002 (Drug)
Cohort A
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.
干预措施: Placebo (Drug)
Cohort A
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.
干预措施: Naropin injection (Drug)
结局指标
主要结局
Vital signs
时间窗: 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.
Physical examination
时间窗: Day 1 to Day 14
Incidence of abnormal clinically significant Physical examination results by Study arm.
Adverse Events
时间窗: 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.
Clinical Laboratory tests
时间窗: 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.
Electrocardiograms
时间窗: Day 1 to Day 14
Incidence of abnormal clinically significant ECG results by Study arm.
次要结局
- Pharmacokinetics(Cmax)(Day 1 to Day 14)
- Pharmacokinetics(AUCt)(Day 1 to Day 14)
- Pharmacokinetics(Vz/F)(Day 1 to Day 14)
- Pharmacokinetics(AUCinf)(Day 1 to Day 14)
- Pharmacokinetics(CL/F)(Day 1 to Day 14)
- Pharmacokinetics(Tmax)(Day 1 to Day 14)
- Pharmacokinetics(t1/2)(Day 1 to Day 14)