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Pharmacokinetics, Safety and Tolerability of Single Sequential and Multiple Intravenous Infusions of Ulinastatin for Injection in Healthy Chinese Participants

2026年11月2日 更新者：Techpool Bio-Pharma Co., Ltd.

A Placebo-Controlled, Double-Blind, Phase I Clinical Study to Evaluate Pharmacokinetic Characteristics, Safety and Tolerability of Single Sequential and Multiple Continuous Intravenous Infusions of Ulinastatin for Injection in Healthy Chinese Participants

This is a Phase 1 clinical study. The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of ulinastatin for injection after single sequential and multiple continuous intravenous infusions in healthy Chinese volunteers.

Key study questions:

  • - How does ulinastatin behave in the body after single sequential and multiple continuous intravenous infusions?
  • - What are the safety outcomes and side effects in healthy people receiving this investigational drug?
  • Study participants will:
  • - Complete screening assessments to check if they meet the study requirements.
  • - Receive either ulinastatin for injection or placebo (inactive substance with no study drug) via intravenous drip.
  • - Follow the study schedule for single sequential infusions and multiple continuous infusions.
  • - Provide blood samples to measure drug concentration in the body.
  • - Undergo safety evaluations including physical examinations, vital sign monitoring and laboratory tests throughout the study period.
  • The study will compare data from participants receiving the study drug versus those receiving placebo to assess drug-related exposure and adverse reactions.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a single-center, randomized, double-blind, placebo-controlled Phase 1 study of ulinastatin for injection in healthy Chinese adults. Approximately 40 participants will be enrolled sequentially into 4 cohorts and randomized 8:2 to ulinastatin or placebo, to evaluate single ascending doses of 100,000 to 8,000,000 units and multiple ascending doses of 400,000 or 1,600,000 units administered three times daily for 4 consecutive days. Serial blood samples will be collected for non-compartmental pharmacokinetic analysis, and safety and tolerability will be assessed throughout the study.

研究类型

介入性

注册 (估计的)

40

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

学习地点

  • 中国
    • Anhui
      • Hefei、Anhui、中国、230601
        • The Second Affiliated Hospital of Anhui Medical University
        • 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 55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:

Participants must meet all of the following criteria to be enrolled:

  1. Healthy Chinese male or female participants, as confirmed by medical history, physical examination, vital signs, 12-lead ECG, chest X-ray, and laboratory tests at screening.
  2. Age 18 to 55 years, inclusive.
  3. Body mass index (BMI) 19.0 to 28.0 kg/m2, inclusive; body weight at least 45.0 kg for women and at least 50.0 kg for men.
  4. Able to understand the procedures and methods of the study, willing to comply strictly with the protocol, and able to provide written informed consent.

Exclusion Criteria:

  • Participants meeting any of the following criteria are not eligible for enrollment:

    1. Smoking more than 5 cigarettes per day within 3 months before screening, or unable to abstain from smoking from 48 hours before dosing through the study period.
    2. Alcohol intake exceeding 14 units per week within 3 months before screening (1 unit = 360 mL of beer, 45 mL of spirits containing 40% alcohol, or 150 mL of wine), or consumption of alcohol-containing products within 48 hours before the first dose, or unable to abstain from alcohol during the study, or a positive blood alcohol test at screening or at admission (Day -2).
    3. History of drug abuse within 6 months before screening.
    4. History or presence of severe cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
    5. History of malignancy of any organ system within 5 years before screening, whether treated or untreated, and regardless of evidence of local recurrence or metastasis.
    6. History of clinically significant electrocardiographic abnormalities.
    7. History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurologic disorders that may alter the absorption, metabolism, or elimination of drugs.
    8. Clinically significant abnormalities in laboratory tests at screening.
    9. History or evidence of renal impairment, manifested as clinically significant abnormalities in creatinine, blood urea nitrogen, or urea, or abnormal urine composition (e.g., proteinuria).
    10. Severe illness, severe infection, or trauma within 2 weeks before dosing.
    11. Blood donation of 400 mL or more within 3 months before dosing, or significant blood loss of at least 400 mL.
    12. Allergic constitution, history of drug or food allergy, or known hypersensitivity to the study drug or to components of similar drugs.
    13. Participation in any other clinical trial and receipt of an investigational drug or device within 3 months before dosing.
    14. Use of prescription drugs, over-the-counter drugs, herbal medicines, or food supplements (including vitamins), or any drug that may interfere with the interpretation of safety data, or any drug or herbal medicine with known common toxicity to major organs, within 2 weeks before dosing.
    15. Surgery within 3 months before the first dose, or planned surgery during the study period.
    16. Pregnant or lactating women, or men or women of reproductive potential who are unwilling to use effective contraception from the start of the study through 90 days after dosing.
    17. Positive test for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.
    18. Difficulty with intravenous administration or blood sampling, or history of needle phobia or hematophobia.
    19. Any other condition that, in the opinion of the investigator, may prevent the participant from completing the study or may place the participant at significant risk.

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：基础科学
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort 1: Ulinastatin single ascending dose (100,000, 2,000,000, and 6,000,000 units)

Participants receive a single 2-hour intravenous infusion of ulinastatin 100,000 units on Day 1, 2,000,000 units on Day 4, and 6,000,000 units on Day 7.
药品：Ulinastatin

Name Ulinastatin for injection

Type Drug

Other Names Ulinastatin; UTI

Lyophilized powder for injection, 100,000 units per vial; white to slightly yellow lyophilized cake or powder. Reconstituted and diluted in 250 mL of 5% glucose injection, then administered by intravenous infusion over 2 hours (±5 minutes). Single doses of 100,000 to 8,000,000 units were administered in the single-ascending-dose cohorts; doses of 400,000 or 1,600,000 units were administered three times daily for 4 consecutive days in the multiple-ascending-dose cohorts. Manufactured by Guangdong Techpool Biochemical Pharmaceutical Co., Ltd.
安慰剂比较：Cohort 1: Placebo

Participants receive a single 2-hour intravenous infusion of placebo (5% glucose injection) on Days 1, 4, and 7, matching the ulinastatin schedule in Cohort 1.
药品：Placebo

Name Placebo

Type Drug

Other Names 5% glucose injection

250 mL of 5% glucose injection, prepared and administered so as to be indistinguishable in appearance from the reconstituted study drug. Contains no active ingredient.
实验性的：Cohort 2: Ulinastatin single ascending dose (1,000,000, 4,000,000, and 8,000,000 units)

Participants receive a single 2-hour intravenous infusion of ulinastatin 1,000,000 units on Day 1, 4,000,000 units on Day 4, and 8,000,000 units on Day 7.
药品：Ulinastatin

Name Ulinastatin for injection

Type Drug

Other Names Ulinastatin; UTI

Lyophilized powder for injection, 100,000 units per vial; white to slightly yellow lyophilized cake or powder. Reconstituted and diluted in 250 mL of 5% glucose injection, then administered by intravenous infusion over 2 hours (±5 minutes). Single doses of 100,000 to 8,000,000 units were administered in the single-ascending-dose cohorts; doses of 400,000 or 1,600,000 units were administered three times daily for 4 consecutive days in the multiple-ascending-dose cohorts. Manufactured by Guangdong Techpool Biochemical Pharmaceutical Co., Ltd.
安慰剂比较：Cohort 2: Placebo

Participants receive a single 2-hour intravenous infusion of placebo (5% glucose injection) on Days 1, 4, and 7, matching the ulinastatin schedule in Cohort 2.
药品：Placebo

Name Placebo

Type Drug

Other Names 5% glucose injection

250 mL of 5% glucose injection, prepared and administered so as to be indistinguishable in appearance from the reconstituted study drug. Contains no active ingredient.
实验性的：Cohort 3: Ulinastatin multiple ascending dose (400,000 units three times daily for 4 days)

Participants receive 2-hour intravenous infusions of ulinastatin 400,000 units three times daily (at 8:00, 16:00, and 23:00, ±1 hour) on Days 1 to 3, and one morning dose on Day 4 (last dose).
药品：Ulinastatin

Name Ulinastatin for injection

Type Drug

Other Names Ulinastatin; UTI

Lyophilized powder for injection, 100,000 units per vial; white to slightly yellow lyophilized cake or powder. Reconstituted and diluted in 250 mL of 5% glucose injection, then administered by intravenous infusion over 2 hours (±5 minutes). Single doses of 100,000 to 8,000,000 units were administered in the single-ascending-dose cohorts; doses of 400,000 or 1,600,000 units were administered three times daily for 4 consecutive days in the multiple-ascending-dose cohorts. Manufactured by Guangdong Techpool Biochemical Pharmaceutical Co., Ltd.
安慰剂比较：Cohort 3: Placebo

Participants receive infusions of placebo (5% glucose injection) three times daily on Days 1 to 3 and one morning dose on Day 4, matching the ulinastatin schedule in Cohort 3.
药品：Placebo

Name Placebo

Type Drug

Other Names 5% glucose injection

250 mL of 5% glucose injection, prepared and administered so as to be indistinguishable in appearance from the reconstituted study drug. Contains no active ingredient.
实验性的：Cohort 4: Ulinastatin multiple ascending dose (1,600,000 units three times daily for 4 days)

Participants receive 2-hour intravenous infusions of ulinastatin 1,600,000 units three times daily (at 8:00, 16:00, and 23:00, ±1 hour) on Days 1 to 3, and one morning dose on Day 4 (last dose).
药品：Ulinastatin

Name Ulinastatin for injection

Type Drug

Other Names Ulinastatin; UTI

Lyophilized powder for injection, 100,000 units per vial; white to slightly yellow lyophilized cake or powder. Reconstituted and diluted in 250 mL of 5% glucose injection, then administered by intravenous infusion over 2 hours (±5 minutes). Single doses of 100,000 to 8,000,000 units were administered in the single-ascending-dose cohorts; doses of 400,000 or 1,600,000 units were administered three times daily for 4 consecutive days in the multiple-ascending-dose cohorts. Manufactured by Guangdong Techpool Biochemical Pharmaceutical Co., Ltd.
安慰剂比较：Cohort 4: Placebo

Participants receive infusions of placebo (5% glucose injection) three times daily on Days 1 to 3 and one morning dose on Day 4, matching the ulinastatin schedule in Cohort 4.
药品：Placebo

Name Placebo

Type Drug

Other Names 5% glucose injection

250 mL of 5% glucose injection, prepared and administered so as to be indistinguishable in appearance from the reconstituted study drug. Contains no active ingredient.

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
Peak plasma concentration(Cmax)
大体时间：Up to 24 hours after the start of each infusion on Days 1, 4, and 7

Descriptive statistics by dose level; non-compartmental analysis.Blood samples were also collected at matching time points on Day -1 (baseline) for endogenous baseline correction.
Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Area under the plasma concentration-time curve from time zero to the last quantifiable
大体时间：Up to 24 hours after the start of each infusion on Days 1, 4, and 7

Descriptive statistics by dose level; non-compartmental analysis.Blood samples were also collected at matching time points on Day -1 (baseline) for endogenous baseline correction.
Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
大体时间：Up to 24 hours after the start of each infusion on Days 1, 4, and 7

Descriptive statistics by dose level; non-compartmental analysis.Blood samples were also collected at matching time points on Day -1 (baseline) for endogenous baseline correction.
Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Time to reach peak plasma concentration (Tmax)
大体时间：Up to 24 hours after the start of each infusion on Days 1, 4, and 7

Descriptive statistics by dose level; non-compartmental analysis.Blood samples were also collected at matching time points on Day -1 (baseline) for endogenous baseline correction.
Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Terminal elimination half-life (t1/2)
大体时间：Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Apparent clearance (CL)
大体时间：Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Apparent volume of distribution (Vz)
大体时间：Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Peak plasma concentration at steady state (Cmax,ss)
大体时间：Up to 24 hours after the start of the Day 4 infusion (last dose)
Up to 24 hours after the start of the Day 4 infusion (last dose)
Trough plasma concentration at steady state (Cmin,ss)
大体时间：Predose on Day 4
Predose on Day 4
Time to reach peak plasma concentration at steady state (Tmax,ss)
大体时间：Up to 24 hours after the start of the Day 4 infusion (last dose)
Up to 24 hours after the start of the Day 4 infusion (last dose)
Area under the plasma concentration-time curve during a dosing interval at steady state (AUC0-tau,ss)
大体时间：Up to 24 hours after the start of the Day 4 infusion (last dose)
Up to 24 hours after the start of the Day 4 infusion (last dose)
Accumulation ratio based on Cmax and AUC0-tau (Rac)
大体时间：Up to 24 hours after the start of the Day 4 infusion (last dose)
Up to 24 hours after the start of the Day 4 infusion (last dose)

次要结果测量

结果测量
大体时间
Incidence and severity of adverse events (AEs)
大体时间：From the first dose up to 7 days (±1 day) after the last dose
From the first dose up to 7 days (±1 day) after the last dose

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。

赞助

Techpool Bio-Pharma Co., Ltd.

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 (估计的)

2026年11月1日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年10月21日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月6日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HJG-WSTD-GDTP

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared. The data are proprietary to the sponsor and are not made available to external parties.

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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