A PhaseⅠ Study of HW252001 in Healthy Subjects

Официальное название

A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HW252001 Tablets After Single and Multiple Dosing in Healthy Subjects

Обзор

This is a phase 1, randomized, double-blind, placebo-controlled, Single/multiple ascending doses (SAD/MAD) study of HW252001 in healthy subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and Pharmacodynamics of HW252001.

Вмешательства

• Препарат HW252001
  HW252001 will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD).
• Препарат Placebo
  Placebo will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD).

Первичные конечные точки

• The number and severity of treatment emergent adverse events (TEAEs) [Срок оценки: up to 11 days]

Вторичные конечные точки (2)

• Cmax [Срок оценки: up to 11 days]
• Tmax [Срок оценки: up to 11 days]

Критерии участия

Критерии включения

• The participant must sign informed consent prior to the trial, understand the trial's content, procedures, and potential adverse reactions, and be able to complete the study in accordance with the trial protocol requirements.
• Healthy male or female subjects, aged ≥18 and ≤55 years on the day of signing the informed consent form.
• During the screening period, male participants must weigh ≥50 kg, and female participants must weigh ≥45 kg. Body Mass Index (BMI) = weight (kg) / height² (m²), and must be within the range of 19 kg/m² to 26 kg/m².

Критерии исключения

• Subjects with a history of malignant tumors (except for cancer with confirmed cure or remission for ≥5 years, radically resected basal or squamous cell skin cancer, carcinoma in situ of the cervix, and resected colonic polyps);
• Subjects judged by the investigator to have any condition or disorder that may affect the absorption, metabolism, and/or excretion of the study drug.
• Subjects with severe infection, severe trauma, or major surgery within 3 months prior to the screening or baseline period; or those with planned surgery during the trial period.
• Subjects with a history of blood donation or significant blood loss (≥400 mL) within 8 weeks prior to the screening or baseline period, or those who have received a blood transfusion within 4 weeks prior to the screening or baseline period; or those who intend to donate blood during the trial period.
• Subjects with a positive result for any of the following at screening: Hepatitis B virus surface antigen (HBsAg), human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, or hepatitis C virus antibody.
• Subjects with a history of heavy smoking (averaging >5 cigarettes per day) within 4 weeks prior to screening or baseline, or those unable to discontinue the use of any tobacco products during the trial period.
• Subjects with an average daily alcohol intake exceeding 15g (equivalent to 450 mL of beer, 150 mL of wine, or approximately 50 mL of low-alcohol liquor) within 4 weeks prior to the screening or baseline period; or those unable to abstain from alcohol during the trial; or those with a positive breath alcohol test at baseline.
• Subjects with a history of drug abuse or drug dependency prior to screening or baseline; or those with a positive urine drug test at baseline.
• Subjects who consumed excessive amounts of tea, coffee, or caffeine-containing beverages (averaging more than 8 cups per day, 250 mL per cup) within 48 hours prior to the first dose.
• Subjects with specific dietary requirements who are unable to comply with the unified diet.
• Subjects allergic to any component of the study drug; or those with a history of allergic diseases or a predisposition to allergies.
• Subjects with dysphagia, difficulty with venous blood collection, or physical conditions that cannot tolerate intensive blood sampling.
• Subjects judged by the investigator as unsuitable to participate in this trial for any other reason.

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

Китай · 1 центр

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07493031 · HW252001-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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