Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women

Официальное название

A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women

Обзор

This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise healthy subjects.

Вмешательства

• Препарат BGM1812
  Administered SC.
• Препарат Placebo
  Administered SC.
• Препарат BGM1812
  Administered SC.
• Препарат Placebo
  Administered SC.

Первичные конечные точки

• Number of treatment adverse events [Срок оценки: Predose up to 6 weeks (Part A) & 9 weeks (Part B)]

Вторичные конечные точки (3)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of BGM1812 [Срок оценки: Predose through week 6 (Part A) & week 9 (Part B)]
• PK: Maximum Observed Concentration (Cmax) of BGM1812 [Срок оценки: Predose through week 6 (Part A) & week 9 (Part B)]
• Pharmacodynamics (PD): Change from baseline in fasting body weight [Срок оценки: Predose through week 6 (Part A) & week 9 (Part B)]

Критерии участия

Критерии включения

• 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.
• Body mass index (BMI) meeting one of the following requirements:

• Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese) (for Cohort 3-6); OR
• Between ≥ 27.0 kg/m2 and < 30.0 kg/m2 (overweight) with at least 1 of the following: One or more symptoms of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia (For Cohort 3- 6); OR
• Between ≥ 23.0 kg/m2 and < 27.0 kg/m2 healthy subjects (for Cohort 1 and Cohort 2)
• Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening

Критерии исключения

• Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to amylin agonist-based therapeutic agents or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
• Known type I/II diabetes.
• Has underwent gastric bariatric surgery in the past, or has had liposuction or fat removal within 1 year before screening, or plan to have bariatric surgery, liposuction or abdominal fat removal during the study period or other surgery that would obviously affect the body weight.
• History of acute or chronic pancreatitis or pancreatic injury.
• 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

США · 1 центр

• Pharmaron CPC, Inc — Baltimore

Идентификаторы

NCT: NCT07224399 · BGM1812-P1-CPK01-US

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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