The First Affiliated Hospital of Yunnan University of Chinese Medicine
Kunming, Yunnan, 650000, China
Location status: Recruiting
NCT Number: NCT07294235
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Phase 1
Kunming, Yunnan, 650000, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AdministeredSC
Administered SC
Time frame: Baseline to Study Completion (Up to 6-9weeks)
Number of participants with AEs and SAEs will be assessed with reference to CTCAE V5.0
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PK Cmax of BGM1812
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PK:AUC of BGM1812
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PD: Changes in fasting blood glucosebefore and after administration, and differences in the amount of change among different dose groups
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PD: Changes in C-peptide before and after administration, and differences in the amount of change among different dose groups
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PD: Changes in insulin before and after administration, and differences in the amount of change among different dose groups
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PD: Changes in body weight before and after administration, and differences in the amount of change among different dose groupsPD: Changes in body weight before and after administration, and differences in the amount of change among different dose groups
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PD: Changes in waist circumference before and after administration, and differences in the amount of change among different dose groups
Time frame: Baseline to Study Completion (Up to 6-9weeks)
Detect the anti-drug antibodies (ADA) of the study drug and their titers; if the ADA is positive, neutralizing antibodies (NAb) will be further detected.
BrightGene Bio-Medical Technology Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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