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Набор скоро начнётся NCT07445906

A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

Фаза I С лечением Renal Impairments IgA Nephropathy (IgAN)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: RG002C0106.
Кому может быть актуально
Состояния в реестре: Renal Impairments, IgA Nephropathy (IgAN). Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

Обзор

This is a Phase I trial designed to evaluate the impact of renal impairment on the efficacy and safety of the drug by comparing pharmacokinetic (PK) parameters and pharmacodynamic (PD) markers after a single subcutaneous injection of RG002C0106 between trial participants with normal renal function and those with mild to moderate renal impairment.

Вмешательства

  • Препарат RG002C0106
    Subcutaneous (SC) single dose 200mg

Первичные конечные точки

  • Calculate the pharmacokinetic (PK) parameters:Cmax [Срок оценки: From enrollment to the end of treatment at 4 days]
  • Calculate the pharmacokinetic (PK) parameters:Tmax [Срок оценки: From enrollment to the end of treatment at 4 days]
  • Calculate the pharmacokinetic (PK) parameters:AUC0-12h , AUC0-24h , AUC0-t, AUC0-∞ [Срок оценки: From enrollment to the end of treatment at 4 days]
  • Calculate the pharmacokinetic (PK) parameters:t½ [Срок оценки: From enrollment to the end of treatment at 4 days]
  • Calculate the pharmacokinetic (PK) parameters:Vd/F [Срок оценки: From enrollment to the end of treatment at 4 days]
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug. [Срок оценки: up to 169 days]

Критерии участия

Критерии включения

  • Have been fully informed about the study, volunteered to participate, and provided written informed consent.
  • Male or female participants aged 18-60 years (inclusive) at screening.
  • Body mass index (BMI) of 19.0-32.0 kg/m² (inclusive) at screening; body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants.
  • Absolute estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI 2021 equation during the screening period, falls into the corresponding group as follows:

Normal renal function: absolute eGFR ≥ 90 mL/min; Mild renal impairment: 60 mL/min ≤ absolute eGFR < 90 mL/min; Moderate renal impairment: 30 mL/min ≤ absolute eGFR < 60 mL/min.

  • Female participants of childbearing potential must have a negative serum pregnancy test during the screening period. Highly effective contraception must be used from signing the informed consent form until 6 months after the last dose of the study drug, by the participant and their partner of childbearing potential.

Критерии исключения

  • At screening, chest radiography demonstrates clinically significant abnormalities.
  • Any of the following abnormal laboratory test results at screening:

Total bilirubin > 1.5 × upper limit of normal (ULN); ALT or AST > 2 × ULN; International normalized ratio (INR) > 2 or any clinically significant abnormality; QTcF ≥ 450 ms in males or QTcF ≥ 470 ms in females (QTc interval must be heart rate-corrected using the Fridericia formula); Other abnormal laboratory test results deemed clinically significant by the investigator.

  • Positive test results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening.
  • Participants with primary or secondary IgA nephropathy (patients with IgA nephropathy are advised to be screened for the Phase IIa study of the investigational product).
  • Current diagnosis of tuberculosis (TB); history of active TB with cure < 5 years prior to screening; or high likelihood of TB infection as judged by the investigator based on comprehensive TB screening during the screening period.
  • Presence or suspected presence of other active viral, bacterial, fungal, or parasitic infections within 4 weeks before screening.
  • History of epidemic meningococcal infection, or other recurrent or chronic infections.
  • History of splenectomy or asplenia.
  • History of complement abnormalities or hereditary complement deficiency.
  • Development of acute kidney injury within 2 weeks before screening.
  • History of renal transplantation, or requirement for renal dialysis during the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07445906 · RG002C0106-102

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗