A Study to Investigate the Safety, Tolerability, and PK of AB102 in Healthy Participants

Официальное название

A Double-Blind, Randomized, Placebo-Controlled, Combined Single Ascending Dose and Multiple Ascending Dose First-In-Human Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AB102 in Healthy Participants

Обзор

The purpose of this study is assess the safety and tolerability of AB102 and characterize the pharmacokinetics (PK) profile of AB102 after single and multiple ascending oral dose(s).

Вмешательства

• Препарат AB102
  Administered orally as specified in the treatment arm
• Другое Placebo
  Administered orally as specified in the treatment arm

Первичные конечные точки

• Number of participants experiencing Adverse Events (AEs) [Срок оценки: Up to 49 days]
• Maximum observed plasma concentration (Cmax) for SAD and MAD Parts [Срок оценки: Up to 28 days]
• Time to attain maximum observed plasma concentration (tmax) for SAD and MAD Parts [Срок оценки: Up to 28 days]
• Terminal elimination half-life (t1/2) for SAD Part [Срок оценки: Up to 28 days]
• Area under the plasma concentration-time curve from time 0 to last sample (AUClast) for SAD and MAD Parts [Срок оценки: Up to 28 days]
• Area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24h) for SAD Part [Срок оценки: Up to 28 days]
• Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) for SAD Part [Срок оценки: Up to 28 days]
• Area under the plasma concentration-time curve over a dosing interval (AUC0-tau) for MAD Part [Срок оценки: Up to 28 days]
• Accumulation ratio (Racc(Cmax))for MAD Part [Срок оценки: Up to 28 days]
• Accumulation ratio(Racc(AUCtau)) for MAD Part [Срок оценки: Up to 28 days]

Критерии участия

Критерии включения

• Understands the study procedures in the Informed Consent Form and is willing and able to comply with the protocol.
• BMI: 19.0 to 30.0 kg/m2, inclusive, at screening.
• All prescribed medication must have been stopped at least 30 days prior to admission to the clinical site. An exception is made for hormonal contraceptives that may be used throughout the study.
• Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, vital signs, and complete neurological examination, as judged by the Investigator.
• Participants must follow protocol-specified contraception guidance.

Критерии исключения

• Have a history of relevant atopy, drug hypersensitivity and/or food allergies.
• Using tobacco products within 3 months prior to the screening.
• Have a significant infection or known inflammatory process on screening or admission.
• Have received any vaccination within 14 days of admission date for non-live vaccines or 28 days of admission date for live attenuated vaccines.
• History of alcohol abuse or drug addiction in the last 2 years (including soft drugs like cannabis products).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07662057 · ARC-102-101 · 2026-526279-52-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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