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A Phase 1 Study of SSS17 in Healthy Subjects.

2021年12月27日 更新者:Shenyang Sunshine Pharmaceutical Co., LTD.

A Phase 1 Study to Evaluate the Tolerance, Safety, Pharmacokinetics and Pharmacodynamics of Oral Administration of SSS17 in Chinese Healthy Adult Subjects With Single and Multiple Dose Escalation and the Effect of Food on the Pharmacokinetics of SSS17.

This study will investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of single oral administration of 5 mg, 15 mg, 20 mg and 25 mg of SSS17 compared with placebo, and evaluate the efficacy, safety, tolerance, pharmacokinetics and pharmacodynamics of multiple oral administration of 15 mg and 20 mg of SSS17 compared with placebo. In addition, the study will assess the effect of food on the pharmacokinetics of SSS17.

研究概览

详细说明

The study will enroll healthy volunteers from a single academic medical center in China. All participants will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures.The study will be divided into 3 parts.

Part 1: Subjects will be allocated 2:8 to receive placebo or SSS17(it was only 2:2 in 5mg dose group),which will be administered by oral route with single dose. At each dose, tolerability, safety, PK and PD characteristics will be investigated.

Part 2: Subjects will be allocated 2:8 to receive placebo or SSS17, which will be administered by oral route with multiple dose. At each cohort,tolerability, safety, PK and PD characteristics will be investigated.

Part 3: The subjects will receive two cycles of treatment, one is given on an empty stomach, the other is given after a high-fat meal, with an interval of 15 days.

研究类型

介入性

注册 (预期的)

76

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Professor Fang, Ph.D
  • 电话号码:13701165926
  • 邮箱:fygk7000@163.com

学习地点

    • Guangdong
      • Guangzhou、Guangdong、中国、510700
        • 招聘中
        • The Fifth Affiliated Hospital of Guangzhou Medical University
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Chinese healthy adult subjects aged 18-45 years (including the boundary value) at the time of signing the informed consent were male and female;
  • In the screening period, the weight of male subjects was more than or equal to 50.0 kg; Female weight ≥ 45.0 kg; Body mass index (BMI) ranged from 19.0 kg / m2 to 26.0 kg / m2 (including boundary value); BMI = weight kg / height m2);
  • Within 6 months from the date of signing the informed consent to the end of the trial, female subjects agreed to take reliable measures to avoid pregnancy and ensure no birth plan, while male subjects agreed to take reliable measures to avoid pregnancy and ensure no birth plan;
  • Willing to participate in the study and sign a written informed consent, able to communicate well with the researchers, and agreed to follow the requirements of the trial protocol and follow-up on schedule.

Exclusion Criteria:

  • Participated in other drug clinical trials within 3 months before screening;
  • Have any clinical history of serious diseases or are suffering from related diseases, including but not limited to digestive system (such as diarrhea, vomiting, inflammatory bowel disease, hemorrhoids, acute gastritis, peptic ulcer, acute and chronic gastrointestinal disorders with obvious digestive and absorption disorders), cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, gastrointestinal tract diseases, etc Diseases of nervous and mental system, blood system, immune system, etc; A history of any disease or thrombotic disease or vascular malformation that increases the risk of bleeding; Patients with dysphagia;
  • Allergic constitution, known allergic to test drug ingredients or allergic history to any drug or food (mango, shrimp, crab, lobster, etc.) or pollen allergy history;
  • Those who smoke more than 5 cigarettes / day or the same amount of tobacco after inquiry, or who can not ban smoking during the trial period; Or alcohol consumption per week is equal to 14 units (1 units 25mL wine Baijiu / 100mL wine / 285mL beer), or those who can not prohibit alcohol during the test period;
  • Have a history of drug abuse or drug abuse;
  • Within 6 months, there were fertility planning, sperm donation and egg donation planning;
  • Patients with lactose intolerance (those who have had diarrhea after drinking milk);
  • Those who have special requirements for diet and cannot accept unified diet;
  • Blood donors or massive blood loss (≥ 400ml), EPO treatment, blood transfusion or use of blood products within 3 months before screening;
  • Those vaccinated within 8 weeks before screening or during the study period;
  • There was a history of acupuncture and blood sickness; Or with orthostatic hypotension;
  • Those who have participated in and used the trial drug;Those who have used any prescription drug, over-the-counter drug, Chinese herbal medicine, vitamins or health care products within 14 days before screening and whose time is less than 5 half-life of the drug or less than 2 weeks (whichever is the longest);
  • The serum pregnancy test of lactating and pregnant women, or female volunteers of childbearing age was positive;
  • The results of physical examination, chest X-ray, color Doppler ultrasound, electrocardiogram and laboratory examination were abnormal and clinically significant; Or hemoglobin of male subjects was more than 175.0 g / L; Or hemoglobin of female subjects was more than 150.0 g / L; Or hemoglobin of male and female were less than 113g / L;
  • Within 48 hours before enrollment, those who took any special diet that affected the absorption, distribution, metabolism and excretion of drugs, including pitaya, mango, grapefruit, lime, carambola or food or drink prepared from them, chocolate, and any food or drink containing caffeine;
  • Urine drug screening test was positive;
  • Alcohol breath test was positive within 24 hours before administration;
  • The researchers think that there are other cases that are not suitable for the trial.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:Part 1: Single Dose Escalation SSS17
Escalating doses of SSS17, single dose administration
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.
安慰剂比较:Part 1: Single Dose Escalation matching Placebo
Escalating doses of matching placebo, single dose administration
匹配的安慰剂。
实验性的:Part 2: Multiple Dose Escalation SSS17
Escalating doses of SSS17, multiple dose administration
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.
安慰剂比较:Part 2: Multiple Dose Escalation matching Placebo
Escalating doses of matching placebo, multiple dose administration
匹配的安慰剂。
实验性的:Part 3: Treatment Sequence 1 (A to B)
The subjects in the first cycle received oral administration of SSS17 on an empty stomach, and subjects in the second cycle received oral administration of SSS17 after a high-fat meal
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.
实验性的:Part 3: Treatment Sequence 2 (B to A)
The subjects in the first cycle received oral administration of SSS17 after a high-fat meal, and the subjects in the second cycle received oral administration of SSS17 on an empty stomach
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.

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
Part 1: AEs
大体时间:Baseline up to Days 15
Assessment AEs by frequency and severity in the part 1
Baseline up to Days 15
Part 1: Maximum plasma concentration (Cmax) of SSS17
大体时间:Up to 336 hours post-dose
Plasma samples will be collected and Cmax will be assessed in the part 1
Up to 336 hours post-dose
Part 1: Area under the concentration-time curve (AUC) of plasma concentration of SSS17
大体时间:Up to 336 hours post-dose
Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 1
Up to 336 hours post-dose
Part 1: Time-to-Cmax (Tmax) of SSS 17
大体时间:Up to 336 hours post-dose
Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 1
Up to 336 hours post-dose
Part 1: Elimination terminal half-life (t1/2) of SSS17
大体时间:Up to 336 hours post-dose
Plasma samples will be collected and the t1/2 will be assessed in the part 1
Up to 336 hours post-dose
Part 1: . Total amount of SSS17 excreted in urine over 72 hours (Ae0-72)
大体时间:Up to 72 hours post-dose
Urine sample will be collected at pre-specified intervals and Ae0-72 will be assessed in the part 1
Up to 72 hours post-dose
Part 1: Fraction of SSS17 excretion during each collection interval (Fe0-72)
大体时间:Up to 72 hours post-dose
Urine sample will be collected at pre-specified intervals and Fe0-72 will be assessed in the part 1
Up to 72 hours post-dose
Part 1: Renal clearance (CLR) of SSS17
大体时间:Up to 72 hours post-dose
Urine sample will be collected at pre-specified intervals and CLR will be assessed in the part 1
Up to 72 hours post-dose
Part 2: AEs
大体时间:Up to Days 33 or 57
Assessment AEs by frequency and severity in the part 2
Up to Days 33 or 57
Part 2: Steady state minimal concentration (Css_min) of SSS17
大体时间:Up to Days 33 or 57
Plasma samples will be collected and Css_min will be assessed in the part 2
Up to Days 33 or 57
Part 2: Steady state maximum concentration (Css_max) of SSS17
大体时间:Up to Days 33 or 57
Plasma samples will be collected and Css_max will be assessed in the part 2
Up to Days 33 or 57
Part 2: Steady state average concentration (Css_av) of SSS17
大体时间:Up to Days 33 or 57
Plasma samples will be collected and Css_av will be assessed in the part 2
Up to Days 33 or 57
Part 2: Area under the concentration-time curve of plasma concentration of SSS17 within the interval of administration after reaching steady state (AUC0-τ)
大体时间:Up to Days 33 or 57
Plasma samples will be collected and the AUC from zero to τ will be assessed
Up to Days 33 or 57
Part 3: Maximum plasma concentration (Cmax) of SSS17
大体时间:Up to Days 44
Plasma samples will be collected and Cmax will be assessed in the part 3
Up to Days 44
Part 3: Area under the concentration-time curve (AUC) of plasma concentration of SSS17
大体时间:Up to Days 44
Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 3
Up to Days 44
Part 3: Time-to-Cmax (Tmax) of SSS 17
大体时间:Up to Days 44
Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 3
Up to Days 44
Part 3: Elimination terminal half-life (t1/2) of SSS17
大体时间:Up to Days 44
Plasma samples will be collected and the t1/2 will be assessed in the part 3
Up to Days 44

次要结果测量

结果测量
措施说明
大体时间
Part 1: EPO concentrations
大体时间:Up to 168 hours post-dose
Change of EPO concentrations from baseline following SSS17 in the part 1
Up to 168 hours post-dose
Part 1: VEGF concentrations
大体时间:Up to 168 hours post-dose
Change of VEGF concentrations from baseline following SSS17 in the part 1
Up to 168 hours post-dose
Part 1: Change of hepcidin from baseline
大体时间:Up to 168 hours post-dose
Change of serum hepcidin concentrations from baseline following SSS17 in the part 1
Up to 168 hours post-dose
Part 1: Change of RTC from baseline
大体时间:Baseline up to Days 15
Change of RTC from baseline following SSS17 in the part 1
Baseline up to Days 15
Part 1: Change of RBC from baseline
大体时间:Baseline up to Days 15
Change of RBC from baseline following SSS17 in the part 1
Baseline up to Days 15
Part 1: Change of Hgb from baseline
大体时间:Baseline up to Days 15
Change of Hgb from baseline following SSS17 in the part 1
Baseline up to Days 15
Part 2: EPO concentrations
大体时间:Up to Days 33 or 57
Change of EPO concentrations from baseline following SSS17 in the part 2
Up to Days 33 or 57
Part 2: VEGF concentrations
大体时间:Up to Days 33 or 57
Change of VEGF concentrations from baseline following SSS17 in the part 2
Up to Days 33 or 57
Part 2: Change of hepcidin from baseline
大体时间:Up to Days 33 or 57
Change of serum hepcidin concentrations from baseline following SSS17 in the part 2
Up to Days 33 or 57
Part 2: Change of RTC from baseline
大体时间:Baseline up to Days 33 or 57
Change of RTC from baseline following SSS17 in the part 2
Baseline up to Days 33 or 57
Part 2: Change of RBC from baseline
大体时间:Baseline up to Days 33 or 57
Change of RBC from baseline following SSS17 in the part 2
Baseline up to Days 33 or 57
Part 2: Change of Hgb from baseline
大体时间:Baseline up to Days 33 or 57
Change of Hgb from baseline following SSS17 in the part 2
Baseline up to Days 33 or 57
Part 3: AEs
大体时间:Up to Days 44
Assessment AEs by frequency and severity in the part 3
Up to Days 44
Part 3: EPO concentrations
大体时间:Up to Days 44
Change of EPO concentrations from baseline following SSS17 in the part 3
Up to Days 44
Part 3: VEGF concentrations
大体时间:Up to Days 44
Change of VEGF concentrations from baseline following SSS17 in the part 3
Up to Days 44
Part 3: Change of hepcidin from baseline
大体时间:Up to Days 44
Change of serum hepcidin concentrations from baseline following SSS17 in the part 3
Up to Days 44
Part 3: Change of RTC from baseline
大体时间:Baseline up to Days 44
Change of RTC from baseline following SSS17 in the part 3
Baseline up to Days 44
Part 3: Change of RBC from baseline
大体时间:Baseline up to Days 44
Change of RBC from baseline following SSS17 in the part 3
Baseline up to Days 44
Part 3: Change of Hgb from baseline
大体时间:Baseline up to Days 44
Change of Hgb from baseline following SSS17 in the part 3
Baseline up to Days 44

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年7月26日

初级完成 (预期的)

2022年12月31日

研究完成 (预期的)

2023年6月30日

研究注册日期

首次提交

2021年5月17日

首先提交符合 QC 标准的

2021年5月17日

首次发布 (实际的)

2021年5月19日

研究记录更新

最后更新发布 (实际的)

2022年1月13日

上次提交的符合 QC 标准的更新

2021年12月27日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • SYSS-SSS17-UND-I-02

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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