A Trial to Compare the Pharmacokinetics of Two Presentations of Navenibart in Healthy Participants
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: Autoinjector, Vial and syringe.
- Кому может быть актуально
- Состояния в реестре: Healthy Adult Participants. 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, Randomized, Open-Label, Parallel-Group Trial Comparing the Pharmacokinetics of Navenibart Administered by Vial/Syringe Versus Autoinjector in Healthy Adult Volunteers
Обзор
The goal of this clinical trial is to compare two different presentations (vial and syringe versus autoinjector) of navenibart in healthy adult volunteers. The main questions it aims to answer are: * Do these presentations lead to similar drug concentrations in the blood? * Do these presentations lead to similar safety and tolerability? Researchers will compare the drug concentrations and safety profile of each group to determine if they are similar. Participants will: * Receive one dose of navenibart with either the vial and syringe or the autoinjector. * Stay in the clinic beginning one day prior to dosing through 2 days after dosing. * Return to the clinic for approximately 9 additional non-residential visits. * Complete medical and other testing, including blood draws.
Вмешательства
- Комбинированный продукт Autoinjector
Navenibart administered subcutaneously via autoinjector - Препарат Vial and syringe
Navenibart administered subcutaneously via vial and syringe
Первичные конечные точки
- Maximum concentration (Cmax) following a single dose of subcutaneous navenibart [Срок оценки: Up to 84 days post dose]
- Area under the concentration versus time curve from time 0 to 84 days (AUC0-84d) following a single dose of subcutaneous navenibart [Срок оценки: Up to 84 days post dose]
Вторичные конечные точки (6)
- Time to reach maximum plasma concentration (Tmax) following a single dose of subcutaneous navenibart [Срок оценки: Up to 140 days post dose]
- Apparent clearance (CL/F) following a single dose of subcutaneous navenibart [Срок оценки: Up to 140 days post dose]
- Apparent volume of distribution during the terminal phase (Vz/F) following a single subcutaneous dose of navenibart [Срок оценки: Up to 140 days post dose]
- Terminal half-life (t1/2) following a single subcutaneous dose of navenibart [Срок оценки: Up to 140 days post dose]
- Incidence of treatment-emergent adverse events (TEAEs), including severity and relationship to navenibart following a single subcutaneous dose of navenibart [Срок оценки: Up to 168 days post dose]
- Incidence and magnitude of treatment-emergent anti-drug antibodies (ADA) [Срок оценки: Up to 140 days post dose]
Критерии участия
Критерии включения
- Males and females 18 to 55 years of age
- In good health, as determined by the Investigator
- Written informed consent, including confirmation of willingness to comply with all trial procedures
- Body weight between 50 and 100 kg, and body mass index (BMI) between 18 and 30 kg/m\^2
- Has not previously received navenibart
- Not pregnant or breastfeeding and agreement to comply with requirements for pregnancy and breastfeeding, contraception use, and egg donation for the specified periods.
Критерии исключения
- Prior or ongoing medical history, or results of a medical assessment, that the Investigator feels could result in a risk to the safety of the participant or the quality of data from the trial.
- Key laboratory results outside of defined ranges
- History or positive test results for tobacco, nicotine products, alcohol, marijuana (cannabis), or drugs of abuse
- Receipt of other prohibited medications, biologic medications, or investigational products within defined windows prior to dosing
- History of severe allergic reactions with an unknown cause
- Donation of blood (at least 500 mL), or any amount of platelets or plasma within defined windows prior to dosing.
- Known hypersensitivity to any component of navenibart
- Any condition that the Investigator feels may affect the ability to provide written informed consent or demonstrates unwillingness or inability to comply with trial procedures
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
- Открытое
- Основная цель
- Другое
Центры проведения
США · 3 центра
- Fortrea Clinical Trials — Daytona Beach
- Fortrea Clinical Trials — Dallas
- Fortrea Clinical Trials — Madison
Идентификаторы
NCT: NCT07635095 · STAR-0215-102