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
Recruiting
Phase 1Interventional Study
HealhtyOverweight or Obesity
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
BrightGene Bio-Medical Technology Co., Ltd. · Industry
Who this trial is looking for
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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.
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Eligibility Criteria
Inclusion Criteria:
* 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 requirement…
Inclusion Criteria:
* 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:
1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese) (for Cohort 3-6); OR
2. 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
3. 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
Exclusion Criteria:
* 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.
Contacts
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