This is a single-center, randomized, double-blind, placebo-controlled, escalating single-dose and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HEC88473 injection in healthy subjects, obese subjects and subjects with type 2 diabetes mellitus (T2DM).
This study is divided into two parts, Part A is an escalating single-dose study in healthy subjects and obese subjects, and Part B is an escalating multiple-dose study in subjects with T2DM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
164
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo will be administered by subcutaneous injection in the abdomen.
The First Hospital of Jilin University
Changchun, Jilin, China
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473
Adverse Events (AEs)
Time frame: Baseline to day 15
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473
Adverse Events (AEs)
Time frame: Baseline to day 43
Cmax
Maximum observed serum concentration of HEC88473
Time frame: Predose and postdose 4、8、10、12、14、24、48、72、96、168、216、336 hours
AUC
Area under the serum concentration-time curve (AUC)
Time frame: Predose and postdose 4、8、10、12、14、24、48、72、96、168、216、336 hours
OGTT
Oral glucose tolerance test
Time frame: Day-1, Day3 and Day 7
Change from baseline of Adiponectin at day 38
Adiponectin
Time frame: Baseline to day 38
Fasting lipid concentration
Fasting lipid concentration
Time frame: Baseline to day 43
Change from baseline of HbA1c at day 38
HbA1c
Time frame: Baseline to day 38
Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing
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anti drug antibodies (ADA)
Time frame: Baseline to day 43