A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function.

Обзор

A clinical study evaluating the pharmacokinetic characteristics and safety of AHB-137 injection in participants with mild to moderate liver dysfunction and those with normal liver function.

Вмешательства

• Препарат AHB-137 injection
  Single use subcutaneous injection

Первичные конечные точки

• Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax) [Срок оценки: Up to day 29]
• Key PK parameters of AHB-137 injection after single subcutaneous administration: area under the drug time curve from 0 to infinity (AUC) [Срок оценки: Up to day 29]

Вторичные конечные точки (6)

• PK parameter: Area under the drug time curve from 0 to the last endpoint quantifiable concentration time point (AUCo- Last) [Срок оценки: Up to day 29]
• PK parameter: Area under the drug time curve from 0 to 24 hours (AUCo-24) [Срок оценки: Up to day 29]
• PK parameter: Area under the drug time curve from 0 to 168 hours (AUCo-168) [Срок оценки: Up to day 29]
• PK parameter: D8 blood concentration (C168) [Срок оценки: Up to day 29]
• PK parameter: peak time (Tmax) [Срок оценки: Up to day29]
• Safety indicators [Срок оценки: Up to day 29]

Критерии участия

Критерии включения

• Voluntarily participate in the study, sign an informed consent form before the study and be able to complete the study according to the requirements of the protocol;
• At the time of signing the informed consent form, male or female participants aged 18-65 years (including threshold values);
• Body mass index meets the criteria;
• Take effective contraceptive measures as required;
• Participants with liver function impairment need to meet certain liver function assessments;
• Participants with normal liver function should meet certain age, weight, and gender requirements to match those with liver function impairment, and should also undergo certain physical and laboratory tests.

Критерии исключения

• Diagnosed or suspected liver cancer participants who have undergone liver transplantation;
• History of vasculitis or presence of signs and symptoms of potential vasculitis or laboratory tests;
• Unstable control of hypertension or diabetes, progressive nervous system disease, history of immune related extrahepatic diseases, and unstable cardiac function;
• Participants with a history of malignant tumors or undergoing malignant tumor assessment;
• Screening for participants who have undergone significant trauma or surgery within the previous 3 months, as well as those who plan to undergo surgery;
• Participants with thyroid dysfunction who are not suitable for inclusion in the study;
• Allergic or allergic constitution to AHB-137;
• Long term regular receipt of anticoagulant or antiplatelet drugs is required;
• Those who have received any antisense oligonucleotide drugs or have been treated with siRNA drugs or interferon within the 12 months prior to screening;
• Currently using or using any immunosuppressive medication within the past 3 months prior to screening, except for short-term use or the use of topical/inhaled steroids; Individuals who have used immunomodulators and cytotoxic drugs within the 6 months prior to administration;
• Those who have a history of vaccination or a plan to receive live vaccines within one month before administration, those who have used creatine containing fitness supplements 14 days before administration, and those who have used albumin 14 days before administration;
• HIV, Syphilis positive ;
• Those who are participating in another clinical trial and have not been eluted as required;
• Positive results in urine drug screening and alcohol breath screening tests during screening;
• Those who drink excessively and consume prohibited foods and beverages before administration;
• Participants who have donated blood (or lost blood) ≥ 400 ml, received whole blood, or used red blood cell suspension within the past 3 months prior to screening; Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection;
• Long term regular vigorous exercise or intense exercise within 48 hours before screening;
• Any other circumstances or conditions that the researcher deems unsuitable for the subject to participate in this study;
• Diseases that need to be excluded according to the merger plan for patients with abnormal liver function;
• The laboratory test results do not meet the requirements of the protocol;
• Participants with normal liver function who have a history of chronic liver disease or known liver or biliary abnormalities;
• Participants with normal liver function who have used traditional Chinese medicine or other systemic medications with potential liver toxicity 14 days before administration;
• Participants with normal liver function and abnormal QTcF values.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• AusperBio Investigational Site — Чунцин
• AusperBio Investigational Site — Чжэнчжоу
• Huashan Hospital Fudan University — Шанхай
• AusperBio Investigational Site — Чэнду
• AusperBio Investigational Site — Ханчжоу

Идентификаторы

NCT: NCT07600788 · AB-10-8010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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