A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Gastrodin Injection in Healthy Chinese Subjects

Обзор

This is a single-center, double-blind study to evaluate the safety, tolerability, pharmacokinetics of Gastrodin Injection in healthy Subjects

Вмешательства

• Препарат gastrodin injection；placebo
  Single-dose intravenous administration of gastrodin injection or placebo
• Препарат gastrodin injection；placebo
  Multiple-dose intravenous administration of gastrodin injection or placebo

Первичные конечные точки

• Adverse Events [Срок оценки: From the initiation of the first administration of the study drug to the completion of the study follow-up .]

Вторичные конечные точки (10)

• Cmax [Срок оценки: Observation was continued until 24 hours after the final administration.]
• Css min [Срок оценки: Observation was continued until 24 hours after the final administration.]
• Css max [Срок оценки: Observation was continued until 24 hours after the final administration.]
• AUC0-t [Срок оценки: Observation was continued until 24 hours after the final administration.]
• AUC0-∞ [Срок оценки: Observation was continued until 24 hours after the final administration.]
• Tmax [Срок оценки: Observation was continued until 24 hours after the final administration.]
• T1/2 [Срок оценки: Observation was continued until 24 hours after the final administration.]
• MRT0-t [Срок оценки: Observation was continued until 24 hours after the final administration.]
• MRT0-∞ [Срок оценки: Observation was continued until 24 hours after the final administration.]
• CL [Срок оценки: Observation was continued until 24 hours after the final administration.]

Критерии участия

Критерии включения

• Subjects must have a full understanding of the trial's purpose, nature, procedures, and potential adverse reactions, voluntarily consent to participate as subjects, sign the informed consent form prior to the initiation of any research procedures, be capable of effective communication with investigators, and understand and comply with all requirements of the study.
• Healthy male or female subjects aged 18 to 65 years (inclusive of boundary values), with a male-to-female ratio of 1:1.
• Male subjects with a body weight ≥ 50.0 kg and female subjects with a body weight ≥ 45.0 kg. body mass index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive of boundary values) .
• Subjects must have no fertility plans during the trial period and within 3 months after the final administration, voluntarily adopt effective contraceptive measures, and have no plans to donate sperm or eggs.

Критерии исключения

• Subjects who developed acute diseases within 2 weeks prior to screening, such as acute gastroenteritis, acute upper respiratory tract infection, acute appendicitis, etc.
• Subjects with a history of any clinically severe diseases or conditions that the investigator deems may interfere with the evaluation of the safety or pharmacokinetic properties of the investigational drug, including but not limited to diseases of the circulatory, respiratory, endocrine, nervous, digestive, urinary systems, as well as hematological, immunological, psychiatric, and metabolic diseases.
• Subjects who underwent major surgery within 6 months prior to screening, or plan to undergo surgery during the study period or within 1 month after the trial completion.
• Subjects with an allergic diathesis (known hypersensitivity to two or more drugs) or known hypersensitivity to Gastrodin Injection and its related excipients.
• Subjects who donated blood within 3 months prior to screening, lost a total of ≥ 400 mL of blood due to blood donation or other causes (excluding normal menstrual blood loss in females) within 6 months prior to screening, or have a history of unexplained abnormal bleeding .
• Subjects who cannot tolerate venipuncture, indwelling needles or have a history of trypanophobia or hematophobia.
• Subjects with special dietary requirements who are unable to comply with the unified diet.
• Subjects who participated in other clinical trials and received investigational drugs or devices within 3 months prior to screening (Note: The end time is defined as the date of the last visit for trial discharge).
• Subjects who received live attenuated vaccine within 2 weeks prior to screening or require live attenuated vaccine during the trial period.
• Subjects who used any medications (including prescription drugs, nonprescription drugs, and Chinese herbal medicines) within 2 weeks prior to screening; Subjects who have consumed strong tea, beverages containing caffeine or alcohol or pomelos, grapefruits and their juices which affect drug metabolism, within 48 hours prior to screening.
• Subjects with an average daily cigarette consumption of more than 5 cigarettes within 3 months prior to screening, or those who cannot discontinue the use of any tobacco products during the trial period.
• Subjects with a history of drug abuse (including non-medical use of various narcotic drugs and psychotropic substances) in the past year, or those with positive results in drug abuse screening (including morphine, methamphetamine, ketamine, ecstasy, tetrahydrocannabinolic acid).
• Subjects with alcoholism, or those who consumed alcohol frequently within 6 months prior to screening (specifically: >14 units per week. 1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of baijiu), or those with a positive alcohol breath test result at screening, or those who cannot abstain from alcohol during the trial period.
• Subjects with clinically significant abnormalities in vital signs assessment, physical examination, chest X-ray (posteroanterior view), clinical laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation function), and 12-lead electrocardiogram.
• Subjects with positive results in any item of infectious disease screening during the screening period (including hepatitis B surface antigen, hepatitis B e antigen, hepatitis B e antibody, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus antibody, syphilis antibody).
• Other subjects deemed unsuitable for participation by the investigator.

Female subjects should also be excluded if they meet the following conditions in addition to the above requirements:

• Those who have had unprotected sexual intercourse with their partners within 14 days before screening.
• Women with positive pregnancy test results or those who are lactating.
• Women whose menstrual period is expected to occur during the drug administration and safety observation period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine — Тяньцзинь

Идентификаторы

NCT: NCT07422142 · KPC-TMS-C101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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