This study is designed to investigate the effect of treatment with Zovaglutide (ZT002 Injection) on the corrected cardiac QT interval relative to a placebo control in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Subjects will receive subcutaneous injections of Zovaglutide (ZT002 Injection) once every two weeks.
Subjects will receive subcutaneous injections of ZT002 injection matching placebo once every two weeks.
Beijing GoBroad Hospital
Beijing, China
Change to baseline- and placebo-corrected QTc interval (ΔΔQTc)
Effect of ZT002 plasma concentrations on the ΔΔQTc interval using linear mixed effect exposure-response modeling.
Time frame: Up to Day 141
Effect of ZT002 plasma concentrations on heart rate (HR)
Measure the Effect of ZT002 plasma concentrations on HR
Time frame: Up to Day 141
Effect of ZT002 plasma concentrations on QT interval corrected using Fridericia's formula (QTcF)
Measure the Effect of ZT002 plasma concentrations on QTcF;
Time frame: Up to Day 141
Effect of ZT002 plasma concentrations on PR interval
Measure the Effect of ZT002 plasma concentrations on PR interval
Time frame: Up to Day 141
Effect of ZT002 plasma concentrations on QRS complex duration
Measure the Effect of ZT002 plasma concentrations on QRS complex duration
Time frame: Up to Day 141
Effect of ZT002 plasma concentrations on T wave
Measure the Effect of ZT002 plasma concentrations on T wave
Time frame: Up to Day 141
Effect of ZT002 plasma concentrations on U wave
Measure the Effect of ZT002 plasma concentrations on U wave
Time frame: Up to Day 141
PK parameter analysis of ZT002 for area under cure from time zero to 72 hours (AUC0-72h)
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Time frame: Up to Day 141
PK parameter analysis of ZT002 for peak concentration (Cmax)
Time frame: Up to Day 141
PK parameter analysis of ZT002 for time to peak concentration (Tmax)
Time frame: Up to Day 141
Incident of anti-drug antibody against ZT002
Time frame: Up to Day 141
Incidence of adverse events (AEs)
Time frame: Up to Day 141
Change in body weight (kg)
Time frame: Up to Day 141
Change in Body Mass Index (BMI) (kg/m²)
Time frame: Up to Day 141
Change in waist circumference (cm)
Time frame: Up to Day 141
Change in hip circumference (cm)
Time frame: Up to Day 141
Change in serum lipid concentrations (high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol, triglycerides) (%)
Time frame: Up to Day 141