Single-ascending Dose Study of HEC-151 Injection

Официальное название

An I-phase Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics of a Single Dose of HEC-151 Injection in Healthy Chinese Participants in a Single-center, Randomized, Placebo (Single-blind) and Positive Control (Open-label) Study

Обзор

Evaluate the safety, tolerability, PK/PD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants

Вмешательства

• Препарат HEC-151 Injection
  Subcutaneous injection in the abdominal area
• Препарат Degludec insulin
  Subcutaneous injection in the abdominal area
• Препарат Placebo
  Subcutaneous injection in the abdominal area

Первичные конечные точки

• Adverse event [Срок оценки: From Day1 to Day36]
• Electrocardiogram parameter（Heart rate） [Срок оценки: From Day1 to Day36]
• Electrocardiogram parameter（PR interval） [Срок оценки: From Day1 to Day36]
• Electrocardiogram parameter（QTcF interval） [Срок оценки: From Day1 to Day36]
• Electrocardiogram parameter(QRS interval) [Срок оценки: From Day1 to Day36]
• Vital signs parameter（Body temperature） [Срок оценки: From Day1 to Day36]
• Vital signs parameter（Blood pressure） [Срок оценки: From Day1 to Day36]
• Vital signs parameter（Pulse） [Срок оценки: From Day1 to Day36]
• Vital signs parameter（Respiration） [Срок оценки: From Day1 to Day36]

Вторичные конечные точки (9)

• Cmax [Срок оценки: From Day1 to Day36]
• AUC0-t [Срок оценки: From Day1 to Day36]
• Tmax [Срок оценки: From Day1 to Day36]
• T1/2 [Срок оценки: From Day1 to Day36]
• CL/F [Срок оценки: From Day1 to Day36]
• GIRmax [Срок оценки: From Day1 to Day36]
• tGIRmax [Срок оценки: From Day1 to Day36]
• AUCGIR [Срок оценки: From Day1 to Day36]
• ADA（Anti-Drug Antibody） [Срок оценки: From Day1 to Day36]

Критерии участия

Критерии включения

• Voluntarily participate in the trial and sign the informed consent form, understanding and abiding by the research procedures;
• When signing the informed consent form, men aged 18-45 years old (including the boundary value) are eligible;
• During the screening process, male subjects with a body weight of ≥ 50 kg and a body mass index (BMI) of ≥ 19.0 and ≤ 24.0 kg/m2 are included;
• Normal glucose tolerance \[3.9 mmol/L < fasting blood glucose (FPG) < 6.1 mmol/L, and 2-hour post-glucose tolerance test (OGTT) blood glucose after sugar intake < 7.8 mmol/L\];
• Normal results of insulin release test (IRT), or abnormal results but judged by the researcher to have no clinical significance;
• Glycated hemoglobin (HbA1c) < 5.7%;
• During the study period, there are no plans for reproduction, sperm collection, or sperm donation, and are willing to take effective contraceptive measures throughout the study period until 3 months after the administration of the investigational drug.

Критерии исключения

• Participants with abnormal medical histories or surgical histories judged clinically significant by the researchers, or currently suffering from any diseases in the endocrine system, blood system, cardiovascular system, respiratory system, digestive system, urinary system, immune system, nervous system, etc. that are judged clinically significant by the researchers, or any other diseases or physiological conditions that can significantly affect the absorption, distribution, metabolism or excretion of the drugs;
• Participants who have a known severe allergic history or are allergic to the test drugs and any of their components;
• Participants who had severe trauma or undergone surgery within 90 days before the screening, or plan to undergo major surgery during the study;
• Participants who have a history of hypoglycemia or hyperglycemia within 90 days before the screening, or have a family history of diabetes (first-degree direct relatives);
• Participants who have donated blood or suffered significant blood loss (≥ 400 mL) within 90 days before the screening, or plan to donate blood during the study;
• Participants who have acute diseases or concurrent medication use from the signing of the informed consent form to the first administration of the drug;
• Participants whose vital signs, physical examination, laboratory tests, electrocardiogram, chest X-ray examination, etc. results are abnormal and judged by the researchers to have clinical significance;
• Participants whose test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), combined human immunodeficiency virus antigen antibody (HIV), or syphilis spirochete antibody (TP) are positive;
• Participants who have a history of drug abuse or drug use, or whose urine drug screening is positive before the screening;
• Participants who have used any prescription drugs, Chinese herbal medicines, over-the-counter drugs, health supplements (except for regular supplementary vitamins and calcium) within 30 days before the screening;
• Participants who have participated in any clinical research of drugs or devices (defined as receiving the test drugs or devices) within 90 days before the screening;
• Participants who have received any vaccine within 30 days before the screening, or plan to receive any type of vaccine during the study;
• Participants who smoke more than 5 cigarettes per day within 90 days before the screening, or cannot comply with the smoking prohibition rule during the study;
• Participants who frequently drink alcohol, that is, consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or have a positive alcohol breath test; or who cannot comply with the alcohol prohibition rule during the study;
• Participants who consume excessive tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup ≈ 250 mL) or food (such as chocolate) every day within 90 days before the screening, or during the study;
• Participants who have used special diets (including dragon fruit, mango, pomelo, etc.) and/or xanthine diet (salmon, sardines, liver, kidney, etc.) or have other factors affecting drug absorption, distribution, metabolism, and excretion before the signing of the informed consent form to the use of the test drugs, or who cannot comply with the prohibition of eating during the study;
• Participants who have had significant changes in diet or exercise habits within 90 days before the screening, or have engaged in intense exercise before the signing of the informed consent form to the use of the test drugs, or cannot stop during the study;
• Participants who have difficulty in venous blood collection, or cannot tolerate venipuncture, or have a history of fainting or hematemesis;
• Participants who, in the researcher's opinion, have other factors that are not suitable for participating in 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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• No. 9, Shuangxing Avenue,, Bishan — Чунцин
• No. 9, Shuangxing Avenue, — Bishan

Идентификаторы

NCT: NCT07376200 · HEC-151-DM-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗