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Идёт набор NCT06800729

A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects

Фаза I С лечением Healthy

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: TIX100, an orally available inhibitor of thioredoxin-interacting protein, Placebo.
Кому может быть актуально
Состояния в реестре: Healthy. Базовые параметры: 18 лет — 70 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
США
Следующий шаг
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Официальное название

A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects

Обзор

A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects

Вмешательства

  • Препарат TIX100, an orally available inhibitor of thioredoxin-interacting protein
    TIX100, an orally available inhibitor of thioredoxin-interacting protein
  • Препарат Placebo
    placebo

Первичные конечные точки

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: Day 7]
  • Number of participants with laboratory analyte results above upper limit of normal. [Срок оценки: Day 7]
  • Number of participants with vital sign results considered clinically significant by the investigator [Срок оценки: Day 7]
  • Number of participants with ECG results considered clinically significant by the investigator [Срок оценки: Day 7]
  • Number of participants with physical examination findings considered clinically significant by the investigator [Срок оценки: Day 7]

Критерии участия

Критерии включения

  • Subjects aged 18-70 years, both genders.
  • Healthy as determined by a physician, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory function. History must comply with the following:
  • Absence of clinically significant illness or surgery within the preceding 12 weeks.
  • Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease.
  • Male subjects with female partners of childbearing potential must agree to utilize condoms for the duration of the study.
  • Female subjects of child-bearing potential with negative urine pregnancy tests and who agree to use double-barrier contraception during the study. The primary contraception may be either hormonal implant or hormonal or non-hormonal intrauterine device, and the secondary (barrier) method of contraception with condom and/or with spermicide.
  • Female subjects of non-child-bearing potential (i.e. tubal ligation, hysterectomy, or postmenopausal).
  • Body mass index (BMI) 18.5 - 29.9 kg/m2
  • HbA1c <6.0%

Критерии исключения

  • History of excessive alcohol use (defined as >21 drinks per week for males and >14 drinks per week for females), recreational drug use or drugs of abuse within the past three months, or failure on urinary drug screen.
  • Pregnant or breastfeeding within six months of screening assessment.
  • Substantial changes in eating habits or exercise routine within the preceding three months.
  • Evidence of eating disorders.
  • >5% weight change in the past three months.
  • Bariatric surgery within the past five years.
  • Significant renal impairment (eGFR <60 mg/mL/1.73m2).
  • Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
  • Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression).
  • Use of drugs approved for the treatment of obesity.
  • Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
  • A baseline prolongation of QT/QTc interval after repeated measurements of >450 ms; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of LQTS.
  • Participation in an investigational drug trial within three months prior to dosing in the present study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • ProSciento, Inc. — Chula Vista

Идентификаторы

NCT: NCT06800729 · TIX100-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗