IPG1094 在健康参与者中的研究
一项 1 期、首次人体、随机、双盲、安慰剂对照、单剂量递增研究，以评估健康成人参与者口服 IPG1094 的安全性、耐受性和药代动力学 (PK)
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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New South Wales
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Randwick、New South Wales、澳大利亚、2031
- Scientia Clinical Research LTD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
参与者必须满足以下所有标准才能被纳入研究：
人口统计
- 18至50岁（含）的健康成年男性或女性参与者。
体重在50-100公斤（含）之间，体重指数（BMI）在18~32公斤/平方米（含）以内。
健康状况
通过筛选测试确定身体健康。 身体健康被定义为通过详细的病史、全面的身体检查（包括测量血压和脉搏率）、12 导联心电图和临床实验室测试确定没有临床相关异常。
生命体征（坐姿休息 5 分钟后测量）在正常范围内，或在正常范围外且研究者认为不具有临床意义。
标准 12 导联心电图参数（仰卧位休息 5 分钟后记录）在以下范围内；校正后的 QT 间期 (QTc)（推荐 Fridericia 算法）≤ 450 ms（男性）和 470 ms（女性），正常 ECG 追踪，或调查员认为临床不相关的异常 ECG 追踪。
实验室参数证明没有临床显着异常，由研究者确定。 如果总胆红素不超过正常 (ULN) 结合胆红素上限的 1.5 倍（记录有吉尔伯特综合征的参与者除外），则总胆红素超出正常范围可能是可以接受的。
- 尿液药物筛查结果为阴性，第 -1 天重复阴性结果（苯丙胺/甲基苯丙胺、巴比妥类药物、苯二氮卓类药物、大麻素、可卡因、鸦片制剂）。
女性参与者不得怀孕或哺乳，并且必须使用有效的避孕方法（如第 4.5.4 节所述），但在过去 3 个月内进行过绝育或绝经后的参与者除外。
有生育能力的女性 (WOCBP) 必须在首次服用试验用药品 (IMP) 之前接受妊娠试验。 如果血清妊娠试验呈阳性，参与者必须被排除在研究之外。
绝经后状态定义为 12 个月的无其他医学原因的闭经。 在没有闭经 12 个月的情况下，可以通过促卵泡激素（FSH）测量（> 40 IU/L 或毫国际单位（mIU）/mL）来确认绝经。接受激素替代疗法 (HRT) 的女性绝经状态不确定，如果参与者希望在研究期间继续他们的 HRT，将需要使用非雌激素激素避孕方法。 参与者必须以其他方式停止 HRT，以便在参加研究之前确认绝经后状态。
规定
- 在进行任何与研究相关的程序之前提供书面知情同意书。
- 不得根据监管或司法命令接受任何行政或法律监督或制度化。
排除标准：
符合以下任何条件的参与者将被排除在研究之外：
病史和临床状况
- 临床相关的心血管、肺、胃肠道、肝、肾、代谢、血液、神经、肌肉骨骼、风湿病、精神病、全身、眼部或传染病的任何病史或存在，或急性疾病的迹象。
- 频繁的剧烈头痛和/或偏头痛、反复出现的恶心和/或呕吐（定义为每月呕吐两次以上）。
- 在第一次给药前的 2 个月内进行过任何体积的献血。
- 有症状的体位性低血压，无论血压实际下降多少，或无症状的体位性低血压伴收缩压在从仰卧位移动到站立位后 3 分钟内下降≥30 mmHg。
- 由医生诊断和治疗的药物超敏反应或过敏反应的存在或病史。
- 已知对 IMP 配方的任何成分过敏。
- 药物或酒精滥用史或存在（定义为每天定期饮酒超过 2 个单位）。
- 经常吸烟（定义为每周超过 5 支香烟或等同物），或在研究期间无法戒烟。 偶尔吸烟的人可能会参加。
过量饮用含黄嘌呤碱的饮料（定义为每天超过 4 杯）。
干扰物质
- 任何药物，包括圣约翰草，在第一次给药前 14 天内或药物消除半衰期或药效半衰期的 5 倍内，激素避孕药、绝经期激素替代疗法或偶尔服用的药物除外扑热息痛剂量高达 2 克/天。
- 在首次给药前 5 天内食用过任何葡萄柚或含有葡萄柚的产品。
第一剂给药前 28 天内的任何疫苗接种。
大体情况
- 任何经研究者判断可能在研究过程中不依从，或因语言问题或智力发育不良而无法合作的参与者。
- 任何参加或参与任何其他涉及试验性医药产品的临床研究，或任何其他类型的医学研究的参与者，在 1 个月内或在首次给药前消除半衰期的 5 倍内。
- 在紧急情况下无法联系到的任何参与者。
作为研究者或任何副研究者、研究助理、药剂师、研究协调员或其直接参与进行研究的其他工作人员的任何参与者，或依赖于研究地点、研究者或研究者的任何人（雇员或直系亲属）赞助。
生物学状态
- 以下任何一项检测呈阳性：乙型肝炎表面抗原（HBsAg）、乙型肝炎核心抗体（HBcAb）、抗丙型肝炎病毒抗体（anti-HCV）、抗人类免疫缺陷病毒1型和2型抗体（anti-HIV1）和抗 HIV2 抗体）。
- 酒精测试呈阳性。
- 任何难以进行静脉采血的参与者。
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：IPG1094 100 mg SAD
Four subjects in this cohort will receive a single dose of IPG1094 100 mg and two subjects will receive a single dose of placebo 100 mg orally.
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a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,100 mg, QD, 1 tablets
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实验性的：IPG1094 300 mg SAD
Six subjects in this cohort will receive a single dose of IPG1094 300 mg and two subjects will receive a single dose of placebo 300 mg orally.
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a Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days,300 mg, QD, 3 tablets
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实验性的：IPG1094 600 mg SAD
Six subjects in this cohort will receive a single dose of IPG1094 600 mg and two subjects will receive a single dose of placebo 600mg orally.
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A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days, 600 mg, QD, 6tablets
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实验性的：IPG1094 900mg SAD
Six subjects in this cohort will receive a single dose of IPG1094 900 mg qd and two subjects will receive a single dose of placebo 900mg qd orally.
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A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，900 mg, QD, 9tablets
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实验性的：IPG1094 1200mg SAD
Six subjects in this cohort will receive a single dose of IPG1094 1200 mg and two subjects will receive a single dose of placebo 1200 mg orally.
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A Single-dose Treatment Period of 1 day, and a Follow-up period of 7 days，1200 mg, QD, 12 tablets
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实验性的：IPG1094 600 mg MAD QD
Dosing begins on Day 1 and continues for 10 days with daily doses of 600 mg QD.
Subjects are discharged on Day 14, followed by a 7-day post-dosing follow-up.
Six subjects in this cohort will receive IPG1094 600 mg and two subjects will receive placebo.
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Dosing begins on Day 1 and continues for 10 days with daily doses of 600 mg QD.
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实验性的：IPG1094 200 mg MAD BID
Dosing begins on Day 1 and continues for 10 days with twice daily 200 mg.
Subjects are discharged on Day 14, followed by a 7-day post-dosing follow-up.
Six subjects in this cohort will receive IPG1094 200 mg nd two subjects will receive placebo.
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Dosing starts on Day 1 and extends over a 10-day period.
Subjects are discharged on Day 13, with a follow-up 7 days after the last dose, each cohort comprises approximately eight subjects, with 6 subjects on IPG1094 and 2 subjects on placebo
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实验性的：IPG1094 300 mg MAD BID
Dosing begins on Day 1 and continues for 10 days with twice daily 300 mg.
Subjects are discharged on Day 14, followed by a 7-day post-dosing follow-up.
Six subjects in this cohort will receive IPG1094 300 mg and two subjects will receive placebo.
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Dosing starts on Day 1 and extends over a 10-day period.
Subjects are discharged on Day 13, with a follow-up 7 days after the last dose, each cohort comprises approximately eight subjects, with 6 subjects on IPG1094 and 2 subjects on placebo
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实验性的：IPG1094 300 mg Fasted-Fed
For Cohort FE-1, Six subjects administration of a single dose of IPG1094 would occur on Day 1 of Period 1 under the fasted condition, and Day 5 (anticipated) of Period 2 under the fed condition.
300 mg per administration.
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For Cohort FE-1, administration of a single dose of IPG1094 would occur on Day 1 of Period 1 under the fasted condition, and Day 5 (anticipated) of Period 2 under the fed condition.
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实验性的：Part D IPG1094 300 mg Fed-Fasted
For Cohort FE-2, Six subjects administration of a single dose of IPG1094 would occur on Day 1 of Period 1 under the fed condition, and Day 5 (anticipated) of Period 2 under fasted condition.
300 mg per administration.
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For Cohort FE-2, administration of a single dose of IPG1094 would occur on Day 1 of Period 1 under the fed condition, and Day 5 (anticipated) of Period 2 under fasted condition.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Adverse Events
大体时间：Part A (SAD)：From signed ICF up to D8；Part B (MAD)：From signed ICF up to D17；Part C (MAD)：From signed ICF up to D17；Part D (FE)：From signed ICF up to D12；
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Evaluation of adverse events
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Part A (SAD)：From signed ICF up to D8；Part B (MAD)：From signed ICF up to D17；Part C (MAD)：From signed ICF up to D17；Part D (FE)：From signed ICF up to D12；
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Cmax
大体时间：Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
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Maximum observed concentration Part A: at 0h before administration(within 1h prior toadministration),0.5,1,1.5,2,2.5,3,4,6,9,12,24,36,48,72,and 96 h after administration. Part B: at 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12,24h after administration on Day 1 and Day 10;at 0h beforeadministration(within 1h prior to administration)on day 4,day 6 and Day 8;at 36,48,72,and 96h after thelast administration on Day 10. Part C: 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12(within 1h before PMadministration),24h(within 1h beforeAMadministration of Day 2)after administration on Day 1 and Day 10;at 0h before administration(within1h priorto AM administration)on day 3,day4,day 5 day 6 and Day 8;at 48,72h after the AM administrationon Day 10. Part D:pre-dose(within 1h before administration),0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,36,48,72h after administration. |
Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
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Tmax
大体时间：Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
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Time of maximum observed concentration Part A: at 0h before administration(within 1h prior toadministration),0.5,1,1.5,2,2.5,3,4,6,9,12,24,36,48,72,and 96 h after administration. Part B: at 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12,24h after administration on Day 1 and Day 10;at 0h beforeadministration(within 1h prior to administration)on day 4,day 6 and Day 8;at 36,48,72,and 96h after thelast administration on Day 10. Part C: 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12(within 1h before PMadministration),24h(within 1h beforeAMadministration of Day 2)after administration on Day 1 and Day 10;at 0h before administration(within1h priorto AM administration)on day 3,day4,day 5 day 6 and Day 8;at 48,72h after the AM administrationon Day 10. Part D:pre-dose(within 1h before administration),0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,36,48,72h after administration. |
Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
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AUC0-t
大体时间：Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
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The parameter would be calculated using the linear trapezoidal rule: Linear up log down. Part A: 0h before administration(within 1h prior toadministration),0.5,1,1.5,2,2.5,3,4,6,9,12,24,36,48,72,and 96 h after administration. Part B: 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12,24h after administration on Day 1 and Day 10;at 0h beforeadministration(within 1h prior to administration)on day 4,day 6 and Day 8;at 36,48,72,and 96h after thelast administration on Day 10. Part C: 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12(within 1h before PMadministration),24h(within 1h beforeAMadministration of Day 2)after administration on Day 1 and Day 10;at 0h before administration(within1h priorto AM administration)on day 3,day4,day 5 day 6 and Day 8;at 48,72h after the AM administrationon Day 10. Part D:pre-dose(within 1h before administration),0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,36,48,72h after administration |
Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
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CL/F
大体时间：Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
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Apparent clearance following extravascular administration, calculated as Dose/AUC0-inf Part A: 0h before administration(within 1h prior toadministration),0.5,1,1.5,2,2.5,3,4,6,9,12,24,36,48,72,and 96 h after administration. Part B: 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12,24h after administration on Day 1 and Day 10;at 0h beforeadministration(within 1h prior to administration)on day 4,day 6 and Day 8;at 36,48,72,and 96h after thelast administration on Day 10. Part C: 0h before AMadministration(within 1h before AM administration),0.5,1,1.5,2,2.5,3,4,6,9,12(within 1h before PMadministration),24h(within 1h beforeAMadministration of Day 2)after administration on Day 1 and Day 10;at 0h before administration(within1h priorto AM administration)on day 3,day4,day 5 day 6 and Day 8;at 48,72h after the AM administrationon Day 10. Part D:pre-dose(within 1h before administration),0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,36,48,72h after administration |
Part A: UP to D5 Part B: UP to D14 Part C: Up to D13 Part D: UP to D12
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合作者和调查者
调查人员
- 首席研究员：Christopher Argent、Scientia Clinical Research LTD
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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