A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of KH607 in Healthy Chinese Participants

Официальное название

A Randomized, Open-Label, 2-period, 2-sequence, Crossover Food-Effect Study of KH607 Tablets in Healthy Chinese Participants

Обзор

This study is a randomized, open-label, 2-period, 2-sequence, crossover food-effect study designed to evaluate the effect of a high-fat meal on the pharmacokinetics of a single oral dose of KH607 tablets in healthy participants, as well as to assess the safety of a single oral dose of KH607 tablets administered under fasting and fed conditions in healthy participants.

Вмешательства

• Препарат KH607
  KH607, single dose, oral
• Препарат KH607
  KH607, single dose, oral

Первичные конечные точки

• AUC0-t [Срок оценки: Up to 96 Hours after study drug administration]
• AUC0-∞ [Срок оценки: Up to 96 Hours after study drug administration]
• Cmax [Срок оценки: Up to 96 Hours after study drug administration]
• The GMRs and their 90% confidence intervals for AUC0-∞ (or AUC0-t and Cₘₐₓ of KH607 tablets under fasting and fed conditions ) [Срок оценки: Up to 96 Hours after study drug administration]

Вторичные конечные точки (6)

• Tmax [Срок оценки: Up to 96 Hours after study drug administration]
• t1/2 [Срок оценки: Up to 96 Hours after study drug administration]
• λz [Срок оценки: Up to 96 Hours after study drug administration]
• tlag [Срок оценки: Up to 96 Hours after study drug administration]
• CL/F [Срок оценки: Up to 96 Hours after study drug administration]
• Safety：Incidence and severity of Adverse Events ( AE)/SAE [Срок оценки: from ICF signing date to day 19 since first dose]

Критерии участия

Критерии включения

• Participants must be healthy and aged ≥18 and <45 years at the time of screening visit.
• Participants must have a body weight equal to or greater than 50 kg (≧45 kg for females ) and a body mass index between 19.0 kg/m2 and 28.0 kg/m2 at the time of screening visit.
• Participants who have no plans for reproduction during the study period and for 3 months following the last dose, must voluntarily agree to use effective and appropriate contraceptive measures, and must have no plans for sperm or egg donation during this period.
• Participant who can understand and comply with the study procedures and requirements, and can provide written informed consent prior to any study procedures shall be included

Критерии исключения

• Participants with known allergy to any ingredient of KH607; or those with a known history of allergy to drugs of the same class; or those with known allergies to two or more other drugs, foods, or environmental factors; or those known to be prone to allergic symptoms such as rash, urticaria, etc. shall be excluded.
• Participants with diseases of the cardiovascular, nervous, respiratory, urinary, digestive, hematologic, endocrine, or immune systems, or psychiatric disorders (including but not limited to: history of epilepsy, Parkinson's disease or other movement disorders, clinically significant history of syncope or vertigo, and any history of psychiatric disorders), which may affect the safety evaluation of the trial, and who, in the opinion of the investigator, are unsuitable for participation in the trial.
• Participants with a history of vestibular dysfunction or severe motion sickness; or a history of ocular disorders such as glaucoma, retinopathy, or other ophthalmic diseases that may cause blurred vision or exacerbate visual adverse effects and are considered clinically significant by the investigator shall be excluded.
• Participants who are unable to Irefrain from driving vehicles, operating hazardous machinery, or working at heights from the time of signing the informed consent form until 1 week after the last dose shall be excluded.
• Participation who have participated in another clinical trial and received an investigational drug, vaccine, or device within 90 days prior to the first dose shall be excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07634874 · KH607-30104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗