Bioequivalence Study of BGM0504 Injection

Официальное название

A Single-Center, Single-Dose, Randomized, Open-Label, Single-Period, Parallel Bioequivalence Study of BGM0504 Injection in Overweight/Obese Participants

Обзор

This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R).

Вмешательства

• Препарат BGM0504 Injection multi-dose pen
  5 mg, single subcutaneous injection in the abdominal region
• Препарат BGM0504 Injection single-dose pen
  5 mg, single subcutaneous injection in the abdominal region
• Препарат BGM0504 Injection single-dose pen
  5 mg, single subcutaneous injection in the abdominal region

Первичные конечные точки

• Peak Plasma Concentration (Cmax) [Срок оценки: 0 to 672 hours]
• Area under the plasma concentration versus time curve (AUC)0-t [Срок оценки: 0 to 672 hours]

Вторичные конечные точки (1)

• Monitor all the adverse event [Срок оценки: 29 days]

Критерии участия

Критерии включения

• Age 18-55 years (inclusive).
• Male weight ≥50 kg, female weight ≥45 kg, and overweight (24.0 ≤ BMI < 28.0 kg/m²) or obese (BMI ≥ 28.0 kg/m²).
• From signing the ICF until 3 months after dosing, no pregnancy plan and willing to use effective contraception to avoid pregnancy or causing partner pregnancy, and no plan for sperm/egg donation.
• The participant fully understands the trial purpose, nature, methods, and potential adverse reactions, can complete the trial according to the protocol, has good living habits, can maintain good communication with the investigator, and voluntarily signs the ICF.

Критерии исключения

• History of severe allergies or severe specific allergic diseases/history (asthma, urticaria, eczematous dermatitis, etc.) or allergic constitution (allergic to two or more foods or drugs), known or suspected allergy to any excipient of BGM0504 Injection.
• Previous diagnosis of type 1 or type 2 diabetes, or clinically significant abnormal HbA1c at screening.
• Family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome.
• History of acute/chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis.
• Past or screening findings of digestive system diseases that may increase participant risk.
• Positive for HBsAg, HCV antibody, syphilis antibody, or HIV antibody at screening.
• Participation in any drug or medical device clinical trial and receiving investigational product/device intervention within 3 months prior to screening.
• Consumption or plan to consume specific foods (including pitaya, mango, grapefruit, pomelo or their juices, high-purine foods like animal organs, seafood, chocolate) or beverages containing caffeine/alcohol within 48 hours before dosing; or unwilling to stop consuming these during the in-house period.
• Pregnant or breastfeeding women, or positive pregnancy test at screening.
• Any other condition considered by the investigator as unsuitable for participation or participant withdrawal due to personal reasons..

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Hangzhou First People's Hospital — Ханчжоу

Идентификаторы

NCT: NCT07382908 · BGM0504-BE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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