Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.

Официальное название

A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of SION-451, and Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.

Обзор

The purpose of Parts D and E of this Phase 1 study are to evaluate the safety, tolerability, and pharmacokinetics of multiple dose combinations of SION-451 and complementary modulators SION-2222 and SION-109 in healthy participants.

Подробное описание

This is a Phase 1 randomized, double-blind, placebo-controlled study. Parts D and E will evaluate the safety, tolerability, and pharmacokinetics of multiple dose combinations of SION-451 and complementary modulators SION-2222 and SION-109 in healthy participants. Parts A, B, and C of this study have completed dosing.

Part D will involve multiple dosing of SION-451 and SION-2222 in combination. Part E will involve multiple dosing of SION-451 and SION-109 in combination.

Вмешательства

• Препарат SION-451
  * Pharmaceutical form: tablet * Route of administration: oral
• Препарат SION-2222
  * Pharmaceutical form: capsule * Route of administration: oral
• Препарат SION-109
  * Pharmaceutical form: tablet * Route of administration: oral
• Препарат Placebo SION-451
  Placebo matched to SION-451
• Препарат Placebo SION-2222
  Placebo matched to SION-2222
• Препарат Placebo SION-109
  Placebo matched to SION-109

Первичные конечные точки

• To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] of SION-451 and SION-109 when administered in combination to healthy participants [Срок оценки: From Day 1 through day 21]
• To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] of SION-451 and SION-2222 when administered in combination to healthy participants [Срок оценки: From Day 1 through day 21]

Вторичные конечные точки (12)

• Cmax of SION-451 and SION-2222 in plasma when administered in combination to healthy participants [Срок оценки: From Day 1 through day 17]
• Tmax of SION-451 and SION-2222 in plasma when administered in combination to healthy participants [Срок оценки: From Day 1 through day 17]
• AUC of SION-451 and SION-2222 in plasma when administered in combination to healthy participants [Срок оценки: From Day 1 through day 17]
• t1/2 of SION-451 and SION-2222 in plasma when administered in combination to healthy participants [Срок оценки: From Day 1 through day 17]
• Volume of distribution of SION-451 and SION-2222 in plasma when administered in combination to healthy participants [Срок оценки: From Day 1 through day 17]
• Apparent total clearance of SION-451 and SION-2222 in plasma when administered in combination to healthy participants [Срок оценки: From Day 1 through day 17]
• Cmax of SION-451 and SION-109 in plasma when administered in combination to healthy participants [Срок оценки: From Day 1 through day 17]
• Tmax of SION-451 and SION-109 in plasma when administered in combination to healthy participants [Срок оценки: From Day 1 through day 17]
• AUC of SION-451 and SION-109 in plasma when administered in combination to healthy participants [Срок оценки: From Day 1 through day 17]
• t1/2 of SION-451 and SION-109 in plasma when administered in combination to healthy participants [Срок оценки: From Day 1 through day 17]
• Volume of distribution of SION-451 and SION-109 in plasma when administered in combination to healthy participants [Срок оценки: From Day 1 through day 17]
• Apparent total clearance of SION-451 and SION-109 in plasma when administered in combination to healthy participants [Срок оценки: From Day 1 through day 17]

Критерии участия

Критерии включения

• Healthy male or female adult participants aged 18 to 55 years, inclusive, at the time of consent.
• Weight of at least 45 kg and body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
• Participant is willing to abstain from alcohol, caffeine, smoking and nicotine-containing products for 72 hours prior to Day -1 through the duration of the study. Participant is willing to abstain from eating cruciferous vegetables, charcoal-grilled meats, and poppy seeds for 48 hours prior to dosing throughout the duration of the study.
• Participant has read, understood, and voluntarily provided written informed consent
• Participant has an understanding, ability, and willingness to fully comply with study procedures and restrictions.

Критерии исключения

• Participant has clinically significant, in the opinion of the investigator, current or recurrent illness, such as cardiovascular (including but not limited to known structural cardiac abnormalities, family history of long QT syndrome, or cardiac syncope or recurrent, idiopathic syncope), neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease or disorder, or other abnormality which may affect safety or clinical laboratory evaluations.
• Participant has a history of malignancy, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of recurrence for at least 1 year.
• Participant has clinically significant abnormalities, in the opinion of the investigator, on ECG, physical examination, or vital sign assessment at Screening or Day -1.
• Participant has any single reading of QTcF >470 ms (females) or >450 ms (males) at Screening or Day -1.
• Chronic or habitual alcohol (>10 standard drinks per week) or tobacco (>10 cigarettes per week) use or use of recreational drugs (>1 use per month). The Investigator may exclude a participant with lower levels of alcohol, tobacco, or recreational drug use based on discretion and the pattern or history of use.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Австралия · 2 центра

• Nucleus Network — Brisbane
• Nucleus Network — Melbourne

Идентификаторы

NCT: NCT07035990 · SION-451-101 · ACTRN12624000849895 · ACTRN12624000848505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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