The goal of this study is to learn about the safety and whether people tolerate a study medicine called efinopegdutide. The study will also measure what happens to efinopegdutide in a healthy person's body over time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
56
Subcutaneous injection
placebo matching efinopegdutide
Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)
Shanghai, Shanghai Municipality, China
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 112 days
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 78 days
Maximum Plasma Concentration (Cmax) of Efinopegdutide- single dose
Blood samples will be collected to determine the Cmax of efinopegdutide when administered as a single dose
Time frame: At designated time points up to 35 days
Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- single dose
Blood samples will be collected to determine the Tmax of efinopegdutide when administered as a single dose
Time frame: At designated time points up to 35 days
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide- single dose
Blood samples will be collected to determine the AUC0-last of efinopegdutide when administered as a single dose
Time frame: At designated timepoints up to 35 days
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of Efinopegdutide- single dose
Blood samples will be collected to determine the AUC0-inf of efinopegdutide when administered as a single dose
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Time frame: At designated timepoints up to 35 days
Terminal half life (t1/2) of Efinopegdutide- single dose
Blood samples will be collected to determine the t1/2 of efinopegdutide when administered as a single dose
Time frame: At designated timepoints up to 35 days
Apparent Clearance (CL) of Efinopegdutide- single dose
Blood samples will be collected to determine the CL of efinopegdutide when administered as a single dose
Time frame: At designated timepoints up to 35 days
Volume of Distribution (Vz) of Efinopegdutide- single dose
Blood samples will be collected to determine the Vz of efinopegdutide when administered as a single dose
Time frame: At designated timepoints up to 35 days
Maximum Plasma Concentration (Cmax) of Efinopegdutide- multiple dose
Blood samples will be collected to determine the Cmax of efinopegdutide when multiple doses are administered
Time frame: At designated time points up to 112 days
Minimum Plasma Concentration (Cmin) of Efinopegdutide- multiple dose
Blood samples will be collected to determine the Cmin of efinopegdutide when multiple doses are administered
Time frame: At designated time points up to 112 days
Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- multiple dose
Blood samples will be collected to determine the Tmax of efinopegdutide when multiple doses are administered
Time frame: At designated time points up to 112 days
Terminal half life (t1/2) of Efinopegdutide- multiple dose
Blood samples will be collected to determine the t1/2 of efinopegdutide when multiple doses are administered
Time frame: At designated timepoints up to 112 days
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide-multiple dose
Blood samples will be collected to determine the AUC0-last of efinopegdutide when multiple doses are administered
Time frame: At designated timepoints up to 112 days
Apparent Clearance (CL) of Efinopegdutide- multiple dose
Blood samples will be collected to determine the CL of efinopegdutide when multiple doses are administered
Time frame: At designated timepoints up to 112 days
Volume of Distribution at Steady State (Vss) of Efinopegdutide- multiple dose
Blood samples will be collected to determine the Vss of efinopegdutide when multiple doses are administered
Time frame: At designated timepoints up to 112 days
Area Under the Concentration-Time Curve to the end of the dosing period (AUC 0-tau)of Efinopegdutide- multiple dose
Blood samples will be collected to determine the AUC0 to tau of efinopegdutide when multiple doses are administered
Time frame: At designated timepoints up to 78 days
Change from Baseline in Weight
Change from baseline in weight will be computed for participants who received multiple doses of efinopegdutide
Time frame: Baseline and day 112
Change from Baseline in HDL Cholesterol
Change from baseline in HDL cholesterol will be computed for participants who received multiple doses of efinopegdutide
Time frame: Baseline and day 112
Change from Baseline in LDL Cholesterol
Change from baseline in LDL cholesterol will be computed for participants who received multiple doses of efinopegdutide
Time frame: Baseline and day 112
Change from Baseline in Total Cholesterol
Change from baseline in total cholesterol will be computed for participants who received multiple doses of efinopegdutide
Time frame: Baseline and day 112
Change from Baseline in Triglycerides
Change from baseline in triglycerides will be computed for participants who received multiple doses of efinopegdutide
Time frame: Baseline and day 112
Number of participants with anti drug antibodies (ADA) to efinopegdutide
Blood samples will be collected to determine the number of participants with ADA to efinopegdutide
Time frame: At designated timepoints up to 112 days