A Study of BGM0504 Tablets in Healthy and Non-diabetic Overweight or Obese Chinese Subjects

Официальное название

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BGM0504 Tablets Orally Administered in Healthy and Non-diabetic Overweight or Obese Chinese Subjects.

Обзор

A Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BGM0504 Tablets Orally Administered in Healthy and Non-diabetic Overweight or Obese Chinese Subjects.

Вмешательства

• Препарат BGM0504 tablets
  Administered p.o.
• Препарат Placebo tablets
  Administered p.o.

Первичные конечные точки

• Number of treatment adverse events [Срок оценки: 8 weeks]

Вторичные конечные точки (2)

• Pharmacokinetic endpoint: Concentration of BGM0504 in plasma [Срок оценки: 8 weeks]
• Change in fasting weight at week 8 [Срок оценки: 8 weeks]

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 < 28 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 the active ingredients and excipients of BGM0504 Tablets), 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.
• At the screening/baseline period, any one of the laboratory test indicators meets the following criteria:

• fasting serum glucose≥ 7.0mmol/L, or post-prandial glucose (PPG)-2h≥ 11.1mmol/L in oral glucose tolerance test (OGTT); (During screening, participants with fasting serum glucose ranging from 6.1 to 6.9mmol/L shall undergo the OGTT.)
• ALT, AST ≥ 2.5 times upper limit of normal (ULN) or total bilirubin ≥ 1.5 times upper limit of normal (ULN)
• Glomerular filtration rate (eGFR) ≤ 80 mL/min/1.73 m2(using CKD-EPI formula) or positive urine protein 2+ or more.
• Serum calcitonin level ≥ 35 ng/L (pg/mL);
• Thyroid-stimulating hormone (TSH) > 6.0mIU/L or < 0.4mIU/L;
• Fasting triglycerides ≥ 5.64mmol/L (500 mg/dL);
• Hemoglobin (Hgb) < 100 g/L (for females) or < 110 g/L (for males);
• 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: NCT07239973 · BGM0504-CPK-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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