A Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants

Официальное название

A Phase I Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants

Обзор

The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.

Вмешательства

• Препарат HRS9531 tablets
  HRS9531 tablets.

Первичные конечные точки

• AUCtau [Срок оценки: 0-24 hours after the 10th dosing.]

Вторичные конечные точки (5)

• Tmax [Срок оценки: First dose at day 1 and post-dose at day 10.]
• Cmax [Срок оценки: First dose at day 1 and post-dose at day 10.]
• t1/2 [Срок оценки: First dose at day 1 and post-dose at day 10.]
• Incidence and severity of adverse events [Срок оценки: Screening period up to Day 45.]
• Anti-HRS9531 antibody [Срок оценки: Before First dose at day 1 to Day 45.]

Критерии участия

Критерии включения

• Ability to understand the trial procedures, be able and willing to provide a written informed consent.
• Male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
• Body weight ≥ 50.0 kg, body mass index (BMI) of 23.0-35.0 kg/m\^2 (both inclusive) at screening.
• Weight change does not exceed 5 kg within 3 months before screening.
• Good general health as judged by the investigator, based on medical history, physical examination, vital signs, clinical laboratory and electrocardiogram (ECG).

Критерии исключения

• Known or suspected hypersensitivity to trial product(s) or related products.
• With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
• Abnormal and clinically significant blood pressure at screening.
• History of significant gastrointestinal diseases or related symptoms (e.g., nausea, vomiting, heartburn, or diarrhea), conditions affecting gastric emptying (e.g., pyloric stenosis), or previous gastrointestinal surgery (excluding polypectomy and appendectomy), or acute diarrhea or constipation within 7 days before randomization.
• Blood donation within 1 month prior to screening, or blood donation ≥ 400 mL or blood loss ≥ 400 mL within 3 months prior to screening.
• Presence of any clinically significant results in examination at screening visit.
• Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
• Presence of - clinically significant ECG results.
• Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
• Addiction to tobacco and alcohol.
• Individuals with special dietary habits deemed unsuitable for participation by the investigator, or those unable to adhere to the dietary requirements of the trial during the study period.
• In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.

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

Лечение

Центры проведения

Китай · 1 центр

• The affiliated hospital of Qingdao University — Qingdao

Идентификаторы

NCT: NCT06506175 · HRS9531-T-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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