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Идёт набор NCT07366866

A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults.

Фаза I С лечением Autoimmune Disease

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: GenSci136, Placebo.
Кому может быть актуально
Состояния в реестре: Autoimmune Disease. Базовые параметры: 18 лет — 45 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
Китай
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 Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of GenSci136 for Injection in Healthy Adult Participants in China.

Обзор

This study is designed to evaluate the safety, tolerability, PK and PD of GenSci136 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.

Вмешательства

  • Препарат GenSci136
    Administered SC.
  • Препарат Placebo
    Administered SC.

Первичные конечные точки

  • ● Incidence and severity of treatment-emergent adverse events (TEAEs) ● Incidence and severity of serious adverse events (SAEs) [Срок оценки: Day1-Day113]
Вторичные конечные точки (10)
  • Serum Concentration of free GenSci136/total GenSci136 [Срок оценки: Day1-Day113]
  • Maximum serum concentration (Cmax) [Срок оценки: Day1-Day113]
  • Time to maximum serum concentration (Tmax) [Срок оценки: Day1-Day113]
  • Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t) [Срок оценки: Day1-Day113]
  • Area under concentration-time from time zero to infinity (AUC0-inf) [Срок оценки: Day1-Day113]
  • Terminal elimination half-life (t1/2) [Срок оценки: Day1-Day113]
  • Clearance (CL/F) [Срок оценки: Day1-Day113]
  • Apparent volume of distribution (Vd/F) [Срок оценки: Day1-Day113]
  • ● Changes from baseline in free and total a proliferation inducing ligand (APRIL) levels; ● Changes from baseline in free and total B-cell activating factor (BAFF) levels. [Срок оценки: Day1-Day113]
  • Incidence and the time of anti-drug antibody (ADA) positive after GenSci136 administration. [Срок оценки: Day1-Day113]

Критерии участия

Критерии включения

  • Male or female, aged 18 to 45 years (both inclusive) at the time of signing informed consent form (ICF).
  • Male body weight ≥ 50 kg or female body weight ≥ 45 kg; BMI between 18-28 kg/m2 (both inclusive) at screening.
  • Males of reproductive age and females of childbearing potential must agree to take highly effective contraceptive methods from screening to the end of the study, and have no plans for conception, sperm donation, or egg donation; females of childbearing potential must have a negative pregnancy test at screening/baseline period and are not breastfeeding.
  • Able to understand the trial procedures, voluntarily participate in the trial, understand and voluntarily sign the ICF, be able to follow all the trial requirements and complete the study.

Критерии исключения

  • Known hypersensitivity to GenSci136 or any of the excipients contained in the GenSci136 formulation, or history of serious hypersensitivity reactions to any drug, compound, food, or other substance, or an allergic constitution.
  • Presence of tattoo, sunburn, scar or any other factors that may interfere with the assessment of the injection site at the intended injection area.
  • A history or presence of other significant metabolic, dermatologic, hepatic, renal, hematologic, cardiovascular, gastrointestinal, psychoneurological, respiratory, and/or other major disease that, in the opinion of the investigator, would affect the evaluation of the study.
  • Any major surgery within 3 months before screening, plan to undergo elective surgery during the study period, or have a history of any surgery that may affect the absorption, distribution, metabolism or excretion of the IMP.
  • Positive result of alcohol breath test, or drug abuser, or use of soft drugs (such as marijuana) within 3 months prior to screening, or use of hard drugs (such as cocaine and ketamine) within 1 year prior to screening, or positive for drug screening \[including but not limited to morphine, ketamine, dimethyldioxyamphetamine, methamphetamine, tetrahydrocannabinol, and cocaine\].
  • Participants judged by the investigator to be ineligible for other reasons.

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
Другое

Центры проведения

Китай · 1 центр
  • Huashan Hospital — Шанхай

Идентификаторы

NCT: NCT07366866 · GenSci136-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗