Pharmacokinetics, Safety and Tolerability of Single Sequential and Multiple Intravenous Infusions of Ulinastatin for Injection in Healthy Chinese Participants
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 1
Контакты и местонахождение
Контакты исследования
- Имя: Mingjuan Hua
- Номер телефона: +86-20-38972288
- Электронная почта: huamj@techpool.com.cn
Места учебы
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Anhui
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Hefei, Anhui, Китай, 230601
- The Second Affiliated Hospital of Anhui Medical University
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Контакт:
- Wei Hu
- Номер телефона: 0551-63869420
- Электронная почта: hwgcp@ayefy.com
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Participants must meet all of the following criteria to be enrolled:
- 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.
- Age 18 to 55 years, inclusive.
- 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.
- 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:
- 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.
- 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).
- History of drug abuse within 6 months before screening.
- History or presence of severe cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- 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.
- History of clinically significant electrocardiographic abnormalities.
- History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurologic disorders that may alter the absorption, metabolism, or elimination of drugs.
- Clinically significant abnormalities in laboratory tests at screening.
- 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).
- Severe illness, severe infection, or trauma within 2 weeks before dosing.
- Blood donation of 400 mL or more within 3 months before dosing, or significant blood loss of at least 400 mL.
- Allergic constitution, history of drug or food allergy, or known hypersensitivity to the study drug or to components of similar drugs.
- Participation in any other clinical trial and receipt of an investigational drug or device within 3 months before dosing.
- 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.
- Surgery within 3 months before the first dose, or planned surgery during the study period.
- 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.
- Positive test for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.
- Difficulty with intravenous administration or blood sampling, or history of needle phobia or hematophobia.
- 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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Последовательное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
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. |
|
Плацебо Компаратор: 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. |
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. |
|
Экспериментальный: 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. |
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. |
|
Плацебо Компаратор: 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. |
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. |
|
Экспериментальный: 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). |
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. |
|
Плацебо Компаратор: 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. |
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. |
|
Экспериментальный: 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). |
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. |
|
Плацебо Компаратор: 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. |
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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Peak plasma concentration(Cmax)
Временное ограничение: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
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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
|
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Area under the plasma concentration-time curve from time zero to the last quantifiable
Временное ограничение: 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)
Временное ограничение: 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
|
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Time to reach peak plasma concentration (Tmax)
Временное ограничение: 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)
Временное ограничение: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
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Up to 24 hours after the start of each infusion on Days 1, 4, and 7
|
|
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Apparent clearance (CL)
Временное ограничение: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
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Up to 24 hours after the start of each infusion on Days 1, 4, and 7
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|
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Apparent volume of distribution (Vz)
Временное ограничение: 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)
Временное ограничение: 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)
|
|
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Trough plasma concentration at steady state (Cmin,ss)
Временное ограничение: Predose on Day 4
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Predose on Day 4
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|
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Time to reach peak plasma concentration at steady state (Tmax,ss)
Временное ограничение: 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)
|
|
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Area under the plasma concentration-time curve during a dosing interval at steady state (AUC0-tau,ss)
Временное ограничение: 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)
|
|
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Accumulation ratio based on Cmax and AUC0-tau (Rac)
Временное ограничение: 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)
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Incidence and severity of adverse events (AEs)
Временное ограничение: From the first dose up to 7 days (±1 day) after the last dose
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From the first dose up to 7 days (±1 day) after the last dose
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HJG-WSTD-GDTP
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Individual participant data will not be shared. The data are proprietary to the sponsor and are not made available to external parties.
Информация о лекарствах и устройствах, исследовательские документы
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