A Clinical Study of AK139 in Healthy Subjects

Официальное название

A Phase I Clinical Study on Dose Escalation Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Dose of AK139 in Healthy Subjects.

Обзор

This is a phase I clinical study on dose escalation evaluating the safety, tolerability, PK and PD of a single dose of AK139 administered subcutaneously in healthy subjects.

Подробное описание

This is a phase I, dose escalation clinical study aimed to evaluate the safety, tolerability, PK and PD of AK139 in healthy subjects. This study will be conducted in a dose escalation design, sequentially increasing the dosage of the drug from low to high to complete a single subcutaneous dose escalation.

Вмешательства

• Препарат Placebo
  Monitor for a minimum of 24 hours to assess whether the safety and tolerability are acceptable according to the investigator.
• Препарат AK111
  The study will use dose escalation scheme. Before proceeding to randomize the next group of subjects, the safety data from all subjects in the previous dose group must be reviewed and confirmed.

Первичные конечные точки

• Adverse Events (AE) [Срок оценки: Baseline to week 12]

Вторичные конечные точки (5)

• Peak concentration (Cmax) [Срок оценки: Week 0 to week 12]
• Time to peak (Tmax) [Срок оценки: Week 0 to week 12]
• Area under the curve (AUC) [Срок оценки: Week 0 to week 12]
• Half-life (t1/2) [Срок оценки: Week 0 to week 12]
• Anti-drug antibody (ADA) [Срок оценки: Week 0/2/4/8/12]

Критерии участия

Критерии включения

• Subjects voluntarily agree to participate and sign an informed consent form (ICF) before any study procedures begin.
• Male and female healthy subjects aged 18 to 55 at the time of signing the ICF.
• Male weight ≥ 50.0kg, female weight ≥ 45.0kg; Body Mass Index (BMI)=Weight (kg)/Height² (m²), within the range of 19.0\~26.0 kg/m².
• Female subjects with fertility tested negative for pregnancy during the screening period.
• The subjects are able to communicate well with the investigator and understand and comply with the requirements of this study.

Критерии исключения

• Allergies to AK139 components and any monoclonal antibodies.
• Positive results of confirmatory serology test for hepatitis B, hepatitis C,HIV or syphilis at screening.
• have participated in any drug clinical study within 3 months prior to randomization, or are still within 5 half-lives after the last administration of other investigational drugs (whichever is longer)
• Previously or currently suffering from any diseases of the circulatory, endocrine, neurological, digestive, respiratory, urogenital, blood, immune, psychiatric, or metabolic systems that may interfere with the test results.
• History of parasitic infection.
• Drug abusers or individuals with positive urine drug results during screening.
• Have donated blood or experienced significant blood loss, received blood transfusions, or used blood products 3 months before screening.
• Investigator assessed that it is not suitable to participate in the study.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhejiang Xiaoshan Hospital — Ханчжоу

Идентификаторы

NCT: NCT06947109 · AK139-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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