NCT07272330招募中1 期
A Phase I Study to Evaluate the Relative Bioavailability of Different HRS-1893 Formulations and the Effect of Food on the Pharmacokinetics of HRS-1893 Tablets in Healthy Subjects
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年12月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Peak concentration (Cmax)
研究概览
简要总结
This Phase I clinical trial will investigate the relative bioavailability between two formulations of HRS-1893 tablets and the influence of food on the drug's pharmacokinetics in healthy adult participants. The safety and tolerability of HRS-1893 will also be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 18 to 55 years (inclusive), regardless of gender.
- •Body mass index (BMI) between 19 and 28 kg/m² (inclusive), with body weight ≥50.0 kg and <90.0 kg for men, and ≥45.0 kg and <90.0 kg for women.
- •No abnormalities of clinical significance are found upon comprehensive physical examination and laboratory tests, or only minor abnormalities that are deemed by the investigator not to affect the subject's eligibility for enrollment.
- •No clinically significant abnormalities on the 12-lead ECG.
- •The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.
排除标准
- •Subjects with suspected hypersensitivity to the investigational drug or any excipient.
- •The subject has a history of syncope.
- •Exclusion due to blood pressure: Systolic Blood Pressure (SBP) >140 mmHg or <90 mmHg; OR Diastolic Blood Pressure (DBP) >90 mmHg or <60 mmHg, as determined by the investigator to be clinically significant.
- •History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption.
- •A positive result in any one of the following infectious disease screening tests during the screening period: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody (syphilis), or human immunodeficiency virus antibody/antigen (HIV-Ab/Ag).
- •Subjects who meet any of the following criteria will be excluded: (1) Smoking: Average daily cigarette consumption of more than 5 cigarettes within the 4 weeks prior to screening. (2) Alcohol: Average daily alcohol intake exceeding 15 g within one week prior to screening (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or 50 mL of low-alcohol spirits). (3) Non-compliance: Inability or unwillingness to abstain from smoking, alcohol, and caffeine-containing foods or beverages during the screening period and the entire study duration. (4) Diet: Have special dietary requirements, cannot comply with the standardized diet provided in the study, or have a history of substance abuse.
- •History of substance abuse.
- •Use of any prescription drugs, over-the-counter medications, or Chinese herbal medicines within 1 month prior to dosing, or the use of any drug within 5 half-lives prior to screening (whichever is longer). Additionally, subjects who plan to take any non-study medications during the trial period will be excluded.
- •Any other circumstances that, in the investigator's judgment, make the subject unsuitable for participation in the trial. This includes physiological or psychological conditions that may increase the trial risk, affect the subject's protocol compliance, or impact the subject's ability to complete the study.
研究组 & 干预措施
HRS-1893 tablet A and HRS-1893 tablet B Group
Experimental
干预措施: HRS-1893 tablet A (Drug)
HRS-1893 tablet A and HRS-1893 tablet B Group
Experimental
干预措施: HRS-1893 tablet B (Drug)
HRS-1893 tablet B Group
Experimental
干预措施: HRS-1893 tablet B (Drug)
结局指标
主要结局
Peak concentration (Cmax)
时间窗: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
时间窗: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t)
时间窗: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
次要结局
- Time to reach peak concentration (Tmax)(From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.)
- Apparent clearance (CL/F)(From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.)
- Apparent volume of distribution (Vz/F)(From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.)
- Elimination half-life (t1/2)(From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.)
- The incidence and severity of any adverse events (AEs)(From Day 1 to Day 29 in part 1, from Day 1 to Day 21 in part 2.)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of BioTTT001Meningeal MetastasisNCT07264569Henan Cancer Hospital42
招募中
1 期
A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal SprayNCT07259538VivaVision Biotech, Inc60
已完成
1 期
Study to Assess Relative Bioavailability of GP681 Formulations in Healthy Chinese Male SubjectsHealthy ParticipantsNCT06678542Jiangxi Qingfeng Pharmaceutical Co. Ltd.36
招募中
2 期
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLCNCT07269782Shanghai Henlius Biotech60
招募中
1 期
A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid TumorsNCT07265921Jiangsu Simcere Pharmaceutical Co., Ltd.232