Clinical Trials of IBI3035 in Healthy Subjects

Официальное название

Evaluation of the Pharmacokinetics and Pharmacodynamics of IBI3035 and Awiqli? (Ecoporin Insulin Injection) in a Randomized, Open-label, Single-dose, Two-formulation, Crossover Design in Healthy Male Subjects in China: A Phase I Clinical Trial.

Обзор

This study is a Phase I clinical trial that uses positive glucose clamping technology to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of IBI3035 with insulin injection (Awiqli?) after a single administration in healthy male subjects

Вмешательства

• Биопрепарат IBI3035
  IBI3035 administered subcutaneously(SC)
• Биопрепарат Insulin icodec Injection
  Insulin icodec Injection administered subcutaneously(SC)

Первичные конечные точки

• The area under the blood drug concentration-time curve from 0 to 168 hours [Срок оценки: From 0 to 168 hours after administration]
• Area Under Curve Glucose Infusion Rate (AUCGIR) 0-168h [Срок оценки: From 0 to 168 hours after administration]

Вторичные конечные точки (12)

• Area Under Curve (AUC0-84h) [Срок оценки: From 0 to 84 hours after administration]
• Tmax [Срок оценки: From 0 to 168 hours after administration]
• Glucose Infusion Rate (GIR) max [Срок оценки: From 0 to 168 hours after administration]
• Area Under Curve Glucose Infusion Rate (AUCGIR) 24-48h [Срок оценки: From 24 to 48 hours after administration]
• Adverse events (AE) [Срок оценки: through study completion, an average of 16 weeks]
• The generation of Anti-drug antibodies (ADA) and Neutrolizing antibodies (NAb if required) [Срок оценки: through study completion, an average of 16 weeks]
• Area Under Curve (AUC) 84-168h [Срок оценки: From 84 to 168 hours after administration]
• Cmax [Срок оценки: From 0 to 168 hours after administration]
• T1/2 [Срок оценки: From 0 to 168 hours after administration]
• tGIRmax [Срок оценки: From 0 to 168 hours after administration]
• AUCGIR 144-168h [Срок оценки: From 144 to 168 hours after administration]
• vital signs (Body temperature) [Срок оценки: through study completion, an average of 16 weeks]

Критерии участия

Критерии включения

The following inclusion criteria must be met:

• Healthy male adult subjects aged 18 to 45 years (including 18 and 45 years, based on the date of signing the informed consent form) of Chinese nationality;
• Body Mass Index (BMI) between 19.0 and 24.0 kg/m2 (including both values) at screening, and weight ≥ 50 kg;
• Normal glucose tolerance at screening \[3.9 mmol/L < fasting blood glucose < 6.1 mmol/L, and 2-hour post-glucose load blood glucose < 7.8 mmol/L in the oral glucose tolerance test (OGTT)\]; normal insulin secretion function or abnormality without clinical significance as determined by the investigator \[confirmed by the insulin release test (IRT)\];
• Glycated hemoglobin ≤ 6.0% at screening;
• Agree to take effective contraceptive measures during the study period and within 6 months after the last dose and have no plan to donate sperm;
• Able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete the trial, and voluntarily sign the informed consent form.

Критерии исключения

Subjects who meet any of the following exclusion criteria cannot be included in this study:

• Known or suspected to be allergic to the investigational drug in this study;
• Have taken any drugs that affect insulin hypoglycemic effects within 28 days before screening (such as corticosteroids, diuretics, epinephrine, salbutamol, glucagon, thyroid hormones, etc.);
• Have a history of clinical significance as determined by the investigator at screening or before randomization, including diseases of the endocrine system, blood system, cardiovascular system, respiratory system, digestive system, urinary system, immune system, nervous system, or any other disease that can significantly alter the absorption, metabolism, or elimination of drugs;
• Have a clear diagnosis of hyperglycemia or hypoglycemia within 3 months before screening;
• Have an increased risk of thrombosis at screening, including personal or family history of deep vein thrombosis;
• Have abnormal indicators with clinical significance at screening or before randomization: vital signs, physical examination, laboratory tests, chest X-ray, and 12-lead ECG as determined by the investigator;
• Have had a severe infection, trauma, or surgery within 4 weeks before screening;
• Have smoked more than 5 cigarettes per day within 3 months before screening, or have smoked within 48 hours before using the investigational drug or cannot stop using any tobacco products during the trial;
• Have used any prescription drugs, Chinese herbal medicines, over-the-counter drugs, or health supplements (except for regular vitamin supplements) within 2 weeks before screening;
• Have donated blood ≥ 400 ml or had any component blood donation within 3 months before screening, or have lost a total of ≥ 400 ml of blood for any reason, or have a history of blood transfusion or use of blood products;
• Have consumed more than 14 units of alcohol per week within 3 months before screening: 1 unit ≈ 360 ml of beer, or 45 ml of spirits, or 150 ml of wine, and cannot abstain from alcohol within 48 hours before using the investigational drug;
• Have consumed excessive amounts of tea, coffee, and/or caffeine-rich beverages (more than 8 cups, 1 cup ≈ 250 ml) daily within 3 months before screening;
• Have positive results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or Treponema pallidum antibodies;
• Have a history of drug abuse or drug use within 3 months before screening, or have positive results for alcohol tests or urine drug screening at screening. 15. Participants who have participated in other clinical trials and used investigational drugs or medical devices within the 3 months prior to screening;

16\. Participants with a weight change greater than 5% within the 3 months prior to screening \[(maximum weight within the 3 months prior to screening - minimum weight within the 3 months prior to screening) / minimum weight within the 3 months prior to screening × 100%, as self-reported by the participant\]; 17. Participants with any food allergies or special dietary requirements that prevent them from adhering to a uniform diet (such as intolerance to standard meal foods, lactose intolerance, etc.); 18. Participants who have experienced acute diseases during the screening period; 19. Participants with a history of fainting at the sight of needles or blood, who cannot tolerate venipuncture blood collection, or who have difficulty with blood collection; 20. Participants for whom the investigator deems there to be any circumstances that make them unsuitable for participation in the trial.

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

Китай · 1 центр

• Bishan Hospital of Chongqing — Чунцин

Идентификаторы

NCT: NCT07591519 · CIBI3035A101CN · MR-50-26-033399

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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