Идёт набор NCT07444294
A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults
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: Placebo, SRK-439, SRK-439.
- Кому может быть актуально
- Состояния в реестре: Healthy. Базовые параметры: 18 лет — 55 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
- 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 1 Single- and Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRK-439 in Healthy Adults
Обзор
A phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439 in healthy adults
Вмешательства
- Препарат Placebo
Matching placebo to SRK-439, subcutaneous administration - Препарат SRK-439
Single ascending dose, subcutaneous administration - Препарат SRK-439
Multiple ascending dose, subcutaneous administration
Первичные конечные точки
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
Вторичные конечные точки (6)
- Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the PD of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
- Evaluate the immunogenicity of single and multiple SRK-439 SC dose administration in healthy adult participants [Срок оценки: Up to 32 weeks]
Критерии участия
Критерии включения
- Male or female participants, ≥18 to ≤55 years of age, at the time of informed consent
- BMI of ≥18 kg/m2 to ≤35 kg/m2 (inclusive) at screening
Критерии исключения
- Previous treatment with SRK-439 or apitegromab, or with other anti-myostatin therapies, including ACTR antagonists.
- History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to screening.
- Current or prior use of anabolic steroids, growth hormones, or other substances with known effects on muscle.
- Use of therapies with potentially significant muscle effects (eg, insulin-like growth factor, systemic beta-agonist, neurotoxins, or muscle relaxants or muscle-enhancing supplements) in any form within 3 months prior to screening or during the study.
- Any history of exposure to a mAb or Fc domain-bearing recombinant protein within 5 years prior to screening with any prior history of hypersensitivity reactions from exposure
- Treatment with other investigational drugs or devices in a clinical study or exposure to a biologic therapeutic within 3 months or 5 half-lives, whichever is longer, prior to screening.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Medpace CPU — Cincinnati
Идентификаторы
NCT: NCT07444294 · SRK-439-001