First-in-human Study of Orally Administered KT-579 in Healthy Adult Participants

Официальное название

A Phase 1, Randomized, Placebo-Controlled, First-in-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered KT-579 in Healthy Adult Participants

Обзор

This is a first-in-human study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of KT-579 in healthy male and female adult participants.

Вмешательства

• Препарат KT-579
  Oral drug
• Препарат Placebo
  Oral drug

Первичные конечные точки

• Incidence of adverse events [Срок оценки: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)]
• Incidence of serious adverse events [Срок оценки: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)]

Вторичные конечные точки (7)

• Maximum concentration (Cmax): observed maximum concentrations derived from plasma concentration data [Срок оценки: Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)]
• Time to maximum concentration (Tmax): observed time to achieve maximum concentrations derived from plasma concentration data [Срок оценки: Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)]
• Area under the curve (AUC0-last): Area under the plasma concentration-time curve calculated using non-compartmental analysis from time zero to the last observed timepoint [Срок оценки: Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)]
• Area under the curve (AUC0-infinity): Area under the plasma concentration-time curve calculated using non-compartmental analysis from time zero to infinite time [Срок оценки: Day 1 (SAD)]
• Area under the curve (AUC0-tau): Area under the plasma concentration-time curve calculated using non-compartmental analysis from time zero to end of the dosing interval [Срок оценки: Day 1, Day 7, and Day 14 (MAD)]
• Terminal elimination half-life (t1/2): elimination half-life calculated using non-compartmental analysis [Срок оценки: Day 1 (SAD) and Day 14 (MAD)]
• Fraction excreted: Fraction of drug excreted unchanged in urine [Срок оценки: Day 14 (MAD)]

Критерии участия

Критерии включения

• Participants with a weight of at least 50 kg if male or 40 kg if female, and a body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at Screening.
• Participants must be willing and able to read, understand, and sign an informed consent form (ICF) which includes compliance with requirements and restrictions listed in the ICF and in this protocol.
• Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Критерии исключения

• Participants who have a clinically relevant history of respiratory, gastrointestinal (GI), renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, ophthalmological, or connective tissue diseases or disorders.
• Participants who have a clinically relevant surgical history (e.g. surgery of the GI tract that could interfere with the PK of the trial medication) Note: prior appendectomy or cholecystectomy is not exclusionary.
• Participants with a history of alcohol or substance abuse within the previous 2 years.
• Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
• Participants who test positive for alcohol and drugs of abuse at Screening and on admission to the CRU.
• Participants who have acute GI symptoms at the time of Screening or on admission to the CRU (e.g. nausea, vomiting, diarrhea, heartburn).
• Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening and on admission to the CRU.
• Participants who have previously received KT-579 in another cohort in this study.
• Participants who have been dosed with any investigational drug or device in a clinical study within 30 days or 5 half-lives (whichever is longer) of KT-579/placebo administration.
• Male participants who do not agree to refrain from sperm donation from admission to the CRU to 90 days after the last dose of study drug.
• Male participants (and their partners of childbearing potential) and female participants who do not agree to the contraception requirements as specified in the clinical protocol.
• Female participants who are pregnant, lactating, or breast-feeding or plan to become pregnant (including ova donation) within 30 days of last study drug administration.
• Female participants with a positive or undetermined pregnancy test at Screening and on admission to the CRU.

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

Другое

Центры проведения

США · 1 центр

• Celerion — Lincoln

Идентификаторы

NCT: NCT07412288 · KT579-HV-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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