A Phase I Study of SNH-119014 in Healthy Volunteers

Официальное название

A Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic of SNH-119014 in Healthy Adult Volunteers

Обзор

SNH-119014 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR) being developed for the treatment of hemolytic anemias. This initial study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of SNH-119014 in the context of Phase 1 studies in healthy volunteers. The effects of food on the absorption of SNH-119014 will also be evaluated in healthy volunteers.

Вмешательства

• Препарат SNH-119014
  study drug
• Препарат Placebo
  placebo

Первичные конечные точки

• Number of Participants With Abnormal Laboratory Values, Clinically Significant Physical Examination Findings, vital signs, electrocardiogram (ECG) and/or Adverse Events/Serious Adverse Events That Are Related to Treatment [Срок оценки: up to 7 days or 20 days]

Критерии участия

Критерии включения

• Healthy male or female subjects;
• 18-45 years of age, inclusive;
• Male subjects with body weight ≥50 kg, female subjects with body weight ≥45 kg; BMI ≥18.5 and ≤28.0 kg/m2.
• Must provide written informed consent.

Критерии исключения

• History of or current clinically significant circulatory system, endocrine system, nervous system, digestive system, respiratory system, urinary system, ophthalmology, hematology, immunology, psychiatry disorder, as judged by the investigator；
• Subjects who have undergone major surgery 6 months prior to screening or who plan to undergo surgery during the study period;
• Clinically significant abnormal physical examination, vital signs, chest X-ray, laboratory tests during the screening period as judged by the investigator;
• Subjects with QTcF>450 ms, or with other ECG clinically significant abnormalities during the screening period as judged by the investigator;
• Subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody at screening;
• Subjects who have a known chronic liver disease, or who have clinically significant abnormal liver function test results during the screening period;
• History of urinary system diseases.
• History of dysphagia or any gastrointestinal disorder affecting drug absorption.
• History of malignancy.
• History of severe allergies or allergic to the study drug or any of its components. Serious adverse reaction or hypersensitivity to any drug or the formulation excipients.
• Failure to follow a consistent diet.
• Over 5 cups (200 ml per cup) of tea, coffee, or caffeinated beverages were consumed daily during the 3 months prior to screening.
• Consumption of a specific diet (e.g. grapefruit and grapefruit-containing products, chocolate, any food containing caffeine), or vigorous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion within 48 hours before the dose of study drug.
• Subjects who have taken any drugs that alter the activity of liver enzymes and/or transporters within 28 days prior to screening.
• Females who are pregnant or lactating and subjects who are unable to use one or more nonpharmacological contraceptives.
• Subjects who have taken any prescribed or over-the-counter drug or herbal remedies or nutraceutical product within 14 days before the dose of study drug.
• Subjects who smoked more than 5 cigarettes per day during the 3 months prior to screening, or who cannot accept a smoking ban throughout the study.
• Alcohol intake >14 units per week within 6 months prior to screening (1 unit is equal to 14g of alcohol such as 360mL of beer, 45mL of 40% spirit, 150mL of wine, or a confirmed positive alcohol breath test, or alcohol prohibition is not acceptable throughout the study.
• History of drug abuse in the past 1 year prior to screening, or a confirmed positive drugs of abuse test result before randomization.
• Subjects who plan to conceive or donate sperm or eggs during the study or within 3 months after completion of study.
• Subjects has received study drug in another clinical study within 3 months before the dose of study drug.
• Subjects who have donated blood or loss ≥400 mL of blood within 3 months before the dose of study drug, or who plan to donate blood or blood components during the study or within 3 months after completion of study.
• Subjects who have received a live attenuated vaccine within 28 days before the dose of study drug.
• Subjects who cannot tolerate venipuncture, or those with a history of needle fainting or blood fainting.
• In the opinion of the investigator, the subject is not suitable for entry into the 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

Четверное слепое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• The Second Hospital of Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07087262 · SNH-119014-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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