A Bioequivalence Study of Two Different Processes of PEG-rhGH Preparations

Официальное название

A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH （2mg/mL）Preparations in Chinese Healthy Adults

Обзор

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

Подробное описание

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

Вмешательства

• Препарат PEG-rhGH with new preparation (T)
  A single subcutaneous injection of PEG-rhGH with new preparation
• Препарат PEG-rhGH with present preparation (T)
  A single subcutaneous injection of PEG-rhGH with present preparation

Первичные конечные точки

• Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation [Срок оценки: 0 hours -408 hours post-administration]
• Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation [Срок оценки: 0 hours -408 hours post-administration]
• Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0- last )) of PEG-rhGH with present and new preparation [Срок оценки: 0 hours -408 hours post-administration]

Критерии участия

Критерии включения

• Healthy male aged ≥18 years old and≤45 years old;
• The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
• Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.

Критерии исключения

• Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing; or a history of allergic diseases (including but not limited to asthma, urticaria, etc.), or allergic constitution (such as known allergy to two or more substances)
• Subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or suggest potential diseases, such as abnormal laboratory test results of liver and kidney function (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] exceeding the upper limit of normal, or total bilirubin exceeding the upper limit of normal; Or blood creatinine exceeding the upper limit of normal value); Or other diseases (such as a history of mental illness) deemed unsuitable for participation in the trials by the investigators;
• Subjects with severe infection, severe trauma, or major surgery within 6 months prior to screening;
• Subjects who have received blood transfusions, had blood donors, or lost blood ≥400 mL within 3 months before screening; Or plan to donate blood within 1 month of the end of the trial;
• Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA);
• Subjects who have participated in clinical trials for medication or medical device within 3 months prior to screening;etc.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• Chengdu Xinhua Hospital — Чэнду

Идентификаторы

NCT: NCT06840691 · GenSci034-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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