A Study of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obese Patients With Multiple Doses

Официальное название

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obese Patients With Multiple Doses

Обзор

This study is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial. This study consists of two parts: the single-dose escalation study (SAD) in healthy subjects and the multiple-dose escalation study (MAD) in obese patients.

Вмешательства

• Препарат SHR-2906 Injection
  SHR-2906 injection, in different doses.
• Препарат SHR-2906 Injection Placebo
  SHR-2906 injection placebo.

Первичные конечные точки

• Incidence of adverse events (AEs). [Срок оценки: Part1: 57 days; Part2: 113 days.]
• Incidence of serious adverse events (SAEs). [Срок оценки: Part1: 57 days; Part2: 113 days.]

Вторичные конечные точки (8)

• Maximum concentration (Cmax). [Срок оценки: Part1: 57 days; Part2: 113 days.]
• Time of maximum concentration (Tmax). [Срок оценки: Part1: 57 days; Part2: 113 days.]
• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last). [Срок оценки: Part1: 57 days; Part2: 113 days.]
• Area under the concentration-time curve from time zero to infinity (AUC0-inf). [Срок оценки: Part1: 57 days; Part2: 113 days.]
• Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau). [Срок оценки: Part1: 57 days; Part2: 113 days.]
• Elimination half-life (t1/2). [Срок оценки: Part1: 57 days; Part2: 113 days.]
• Apparent clearance (CL/F). [Срок оценки: Part1: 57 days; Part2: 113 days.]
• Apparent volume of distribution (Vz/F). [Срок оценки: Part1: 57 days; Part2: 113 days.]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol;
• Males or females aged 18-55 years (inclusive);
• Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG);
• At screening, 19.0 ≤ BMI ≤ 23.9 kg/m2 (inclusive) for Part I or 28.0 ≤ BMI ≤ 35.0 kg/m2 (inclusive) for Part II.

Критерии исключения

• During screening, electrocardiogram (ECG) indicated that QTcF>450 ms in males and QTcF> 470 ms in females, as well as other abnormal ECG and vital signs that were judged by the researchers to have clinical significance;
• There are endocrine diseases or medical histories that may significantly affect body weight during screening (such as Cushing's syndrome, diabetes, hypothyroidism or hyperthyroidism, etc.);
• There is a history or family history of medullary thyroid carcinoma, multiple endocrine adenomatosis type 2, or a history of pancreatitis or symptomatic gallbladder disease;
• Other clinical findings within 12 months prior to screening that show clinical significance in the following diseases (including but not limited to gastrointestinal, kidney, liver, nervous, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases);
• Use of prescription drugs (excluding topical eye/nasal drops and creams without systemic exposure risk), over-the-counter drugs, food supplements, vitamins and Chinese herbal medicines (excluding conventional vitamins) within two weeks prior to screening;
• Having undergone gastrointestinal surgery that may cause malabsorption before screening, or having taken drugs that directly affect gastrointestinal peristalsis for a long time. For example: having undergone bariatric surgery or procedures (such as gastric banding), or having used weight-reducing drugs (including but not limited to orlistat) within 3 months before administration, or having a weight change of more than 10% within 3 months before administration;
• Those who have a history of drug abuse in the past five years or have used drugs in the three months prior to the trial; Or the urine drug screening is positive;
• Blood donation of ≥200 mL within one month prior to screening; Or those who have donated ≥400 mL of blood or lost ≥400 mL of blood within 3 months prior to screening due to trauma or major surgical operations;
• Inability to tolerate venipuncture for blood collection or fainting at the sight of needles and blood;
• There are special dietary requirements and they cannot follow the uniform diet;
• Subjects who the researchers consider to have other factors that make them unsuitable for participating in this trial.

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

• Hangzhou First People's Hospital — Ханчжоу

Идентификаторы

NCT: NCT07280936 · SHR-2906-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗