A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects
This is the first time HEC88473 will be administered to humans. The aim of this study is to obtain safety, tolerability, PK, PD, and immunogenicity data of HEC88473 SC administration as single and multiple ascending doses in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
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
Scientia Clinical Research
Sydney, Australia
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473
Time frame: Baseline to day 15
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473
Time frame: Baseline to day 43
Cmax
Maximum observed plasma concentration of HEC88473
Time frame: Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
AUC
Area under the plasma concentration-time curve (AUC)
Time frame: Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
OGTT
Oral glucose tolerance test
Time frame: Predose and postdose 2, 4 hours
Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing
Time frame: Baseline to day 43
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