NCT06039254尚未招募1 期
A Multicenter, Non-randomized, Open-label, Parallel-controlled Study to Evaluate the Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
Shandong Suncadia Medicine Co., Ltd.0 个研究点目标入组 27 人开始时间: 2023年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
- 主要终点
- Pharmacokinetics-Cmax
研究概览
简要总结
This is a multicenter, non-randomized, open-label, parallel-controlled study. The main objective is to evaluate the safety and pharmacokinetics of HRS-1780 in subjects with mild and moderate renal impairment versus healthy subjects, and to provide a basis for dose selection of HRS-1780 in patients with chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects：
- •Able to understand the trial procedures and possible risks, volunteers to participate in the trial, willing and able to comply with all scheduled visits and study procedures, and provides written informed consent.;
- •Male and female, 18 to 70 years of age, inclusive;
- •Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive;
- •Normal glomerular filtration rate;
- •No clinically significant abnormalities in physical examination, vital signs, laboratory tests, 12-lead ECG, etc. at the investigator's discretion;
- •Men and WOCBP must agree to take highly effective contraceptive methods detailed in the protocol, have no plan to have a child from signing the consent form until at least one month after IP administration, and must not undertake for sperm/egg donation. Female participants should not be lactating.
- •Renal impairment subjects：
- •Able to understand the trial procedures and possible risks, volunteers to participate in the trial, willing and able to comply with all scheduled visits and study procedures, and provides written informed consent.;
- •Male and female, 18 to 70 years of age, inclusive;
- •Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive;
- •Glomerular filtration rate between 30 to 89 mL/min, inclusive;
- •Except for renal impairment and related complications, no clinically significant abnormalities in physical examination, vital signs, laboratory tests, 12-lead ECG, etc. at the investigator's discretion;
- •Men and WOCBP must agree to take highly effective contraceptive methods detailed in the protocol, have no plan to have a child from signing the consent form until at least one month after IP administration, and must not undertake for sperm/egg donation. Female participants should not be lactating.
排除标准
- •Healthy subjects：
- •Known history or suspected of being allergic to study drug or any component of it, or significant allergic reactions to other biologic products and drugs, or severe food allergies;
- •Clinically significant abnormalities in 12-Lead ECG;
- •Severe infections, injuries, or major surgeries as determined by the investigator within 3 months prior to screening, or plans to have surgeries during the study;
- •Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, whichever is longer prior to screening, or plans to participate in another clinical study during this study;
- •Use of any prescription medicine, over-the-counter medicine, herbal remedy, or nutritional supplement within 2 weeks prior to screening;
- •Consumption of more than 14 units of alcohol per week within 6 months prior to screening, or incapable to refrain from consuming alcohol during the study, or positive alcohol breath test result;
- •Consumption of more than 5 cigarettes daily (or products with an equivalent amount of nicotine) within 3 months prior to screening, or use of any tobacco products 48 hours prior to dosing;
- •History of illicit or prescription drug abuse or addiction in the past 5 years, or illicit or prescription drug abuse within 3 months prior to screening, or positive urine drug screen;
- •Unwilling or unable to comply with the contraceptive methods detailed in this protocol;
- •Positive hepatitis B virus, hepatitis B core antibody, hepatitis C virus, human immunodeficiency virus, or syphilis at screening;
- •History or evidence of clinically significant disorders and deemed not suitable to participate in the study by the investigator within 6 months prior to screening;
- •Inability to tolerate venipuncture blood collection;
- •Any other circumstances that, in the investigator's judgment, may increase the risk to the subject, or associated with the subject's participation in and completion of the study.
- •Renal impairment subjects：
- •History of kidney transplant or plan to receive a kidney transplant during the trial;
- •Known history or suspected of being allergic to study drug or any component of it, or significant allergic reactions to other biologic products and drugs, or severe food allergies;
- •Clinically significant abnormalities in 12-Lead ECG;
- •Severe infections, injuries, or major surgeries as determined by the investigator within 3 months prior to screening, or plans to have surgeries during the study;
- •Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, whichever is longer prior to screening, or plans to participate in another clinical study during this study;
- •Except for treatment of renal impairment and related complications, use of other prescription medicine, over-the-counter medicine, herbal remedy, or nutritional supplement within 2 weeks prior to screening;
- •Consumption of more than 14 units of alcohol per week within 6 months prior to screening, or incapable to refrain from consuming alcohol during the study, or positive alcohol breath test result;
- •Consumption of more than 5 cigarettes daily (or products with an equivalent amount of nicotine) within 3 months prior to screening, or use of any tobacco products 48 hours prior to dosing;
- •History of illicit or prescription drug abuse or addiction in the past 5 years, or illicit or prescription drug abuse within 3 months prior to screening, or positive urine drug screen;
- •Unwilling or unable to comply with the contraceptive methods detailed in this protocol;
- •Positive hepatitis B virus, hepatitis B core antibody, hepatitis C virus, human immunodeficiency virus, or syphilis at screening;
- •History or evidence of clinically significant disorders and deemed not suitable to participate in the study by the investigator within 6 months prior to screening;
- •Inability to tolerate venipuncture blood collection;
- •Any other circumstances that, in the investigator's judgment, may increase the risk to the subject, or associated with the subject's participation in and completion of the study.
研究组 & 干预措施
Healthy subjects group
Experimental
干预措施: HRS-1780 (Drug)
Mild renal impairment group
Experimental
干预措施: HRS-1780 (Drug)
Moderate renal impairment group
Experimental
干预措施: HRS-1780 (Drug)
结局指标
主要结局
Pharmacokinetics-Cmax
时间窗: Start of Treatment to end of study (approximately 1 week)
Maximum observed concentration of HRS-1780
Pharmacokinetics-AUC0-last
时间窗: Start of Treatment to end of study (approximately 1 week)
Area under the concentration-time curve from time 0 to last time point after HRS-1780 administration
Pharmacokinetics-AUC0-inf
时间窗: Start of Treatment to end of study (approximately 1 week)
Area under the concentration-time curve from time 0 to infinity after HRS-1780 administration
次要结局
- Pharmacokinetics-t1/2(Start of Treatment to end of study (approximately 1 week）)
- Pharmacokinetics-Cumulative excretion rate (Ae%)(Start of Treatment to end of study (approximately 1 week))
- Pharmacokinetics-Tmax(Start of Treatment to end of study (approximately 1 week))
- Pharmacokinetics-CL/F(Start of Treatment to end of study (approximately 1 week))
- Adverse events(Start of Treatment to end of study (approximately 1 week))
- Pharmacokinetics-Vz/F(Start of Treatment to end of study (approximately 1 week))
- Pharmacokinetics-Renal clearance (CLr)(Start of Treatment to end of study (approximately 1 week))
- Pharmacokinetics-Cumulative excretion (Ae)(Start of Treatment to end of study (approximately 1 week))
- Binding rates of plasma protein (BRPP) of HRS-1780(Start of Treatment to end of study (approximately 1 week))
研究者
相似试验
Unknown
不适用
Safety and Efficacy of the SETA LATECBA Stent Graft for EVAR in Subjects With AAAAbdominal Aortic AneurysmNCT04220177Latecba S.A.42
尚未招募
1 期
Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With RitonavirRenal ImpairmentHepatic ImpairmentNCT05731804Jiangsu Simcere Pharmaceutical Co., Ltd.72
撤回
不适用
The Evaluation of the DIMI RRT System In-Center to Demonstrate Safety and Usability in the Home EnvironmentHemodialysisESRDNCT04868643Dialco Medical Inc.
招募中
2 期
Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate CancerNeoadjuvant TherapyHigh Risk Prostate CancerLocally Advanced Prostate CancerIntense Endocrine TherapyNCT05406999The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School900
已完成
1 期
Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic FunctionNCT06736223Italfarmaco24