A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants

Официальное название

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of BGM1812 in Healthy and Non-diabetic Overweight or Obese Chinese Participants

Обзор

The purpose of this study is to evaluate the tolerability , safety and pharmacodynamics of BGM1812 administered subcutaneously in healthy and non-diabetic overweight or obese Chinese participants, and to investigate the pharmacokinetic profile of BGM1812 in the bloodstream.

Вмешательства

• Препарат BGM1812
  AdministeredSC
• Препарат Placebo
  Administered SC
• Препарат BGM1812
  Administered SC
• Препарат Placebo
  Administered SC

Первичные конечные точки

• Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator [Срок оценки: Baseline to Study Completion (Up to 6-9weeks)]

Вторичные конечные точки (8)

• Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812 [Срок оценки: Baseline to Study Completion (Up to 6-9weeks)]
• PK: Area Under the Concentration Versus Time Curve (AUC) of BGM1812 [Срок оценки: Baseline to Study Completion (Up to 6-9weeks)]
• Pharmacodynamics (PD): Fasting Blood Glucose of BGM1812 [Срок оценки: Baseline to Study Completion (Up to 6-9weeks)]
• PD:C-Peptide of BGM1812 [Срок оценки: Baseline to Study Completion (Up to 6-9weeks)]
• PD: Insulin of BGM1812 [Срок оценки: Baseline to Study Completion (Up to 6-9weeks)]
• PD: Body Weight of BGM1812 [Срок оценки: Baseline to Study Completion (Up to 6-9weeks)]
• PD: Waist Circumference of BGM1812 [Срок оценки: Baseline to Study Completion (Up to 6-9weeks)]
• Immunogenicity Endpoints [Срок оценки: Baseline to Study Completion (Up to 6-9weeks)]

Критерии участия

Критерии включения

• Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese subjects , both male and female;
• Healthy subjects , male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 20.0 kg/m² ≤ BMI < 24 kg/m²（BMI = weight/height²）;
• Obese individuals: BMI ≥ 28.0 kg/m², or overweight individuals: 24.0 kg/m² ≤ BMI < 28.0 kg/m²;
• (Medical Inquiry) Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening.
• Have no history of mental disorders, be able to communicate smoothly with Investigator, Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.
• Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional medically acceptable form of contraception (female partner) for the duration of the study and for at least 3 months after dosing; must also agree to refrain from sperm donation for at least 3 months post dose.

Критерии исключения

• Those with a history of severe drug allergies (especially those with known or suspected allergies to related compounds of BGM1812), or complicated with severe specific allergic diseases/history, or with a severe allergic constitution.
• Subjects with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period.
• 12-lead ECG shows ventricular heart rate < 50 beats/min or > 100 beats/min at screening/baseline, second or third degree atrioventricular block, long QT syndrome, QTcF> 470ms for women or > 450ms for men, pre-excitation syndrome or other significant arrhythmias.
• Used illegal drugs within 6 months prior to screening, or substance abuse within 12 months prior to screening.
• Participated in drug or medical device clinical trials and treated with Study Drug (excluding placebo) or medical device intervention within 12 weeks before screening.
• Participants who have received any vaccine within 2 weeks prior to screening, or plan to receive a vaccine during the trial.
• Female participants who are pregnant or lactating, or those with a positive pregnancy test result during the screening period.
• Positive urine drug test or alcohol serum test result at screening or at baseline.
• Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Yunnan University of Chinese Medicine — Куньмин

Идентификаторы

NCT: NCT07294235 · BGM1812-CPK-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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