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.
Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
Age between 18 - 45 years (both inclusive) at the time of signing of the informed consent;
Male (body weight >60.0 kg) or female (body weight >55.0 kg). Body mass index (BMI) 24.0 - 35.0 kg/m²(both inclusive);
Known hypersensitivity (asthma, hypersensitivity to GLP-1 receptor agonists or excipients), or known hypersensitivity to ZT002 injection;
History of acute or chronic pancreatitis, or pancreatic injury.History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
Has a history of cardiovascular diseases or risk factors predisposing to torsades de pointes (TdP); has personal or family history of any cardiac conduction abnormalities; has personal or family history of long QT syndrome (LQTS); or has a family history of sudden cardiac death.
Those with any type of malignant tumors within 5 years prior to screening (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
Parallel
ZT002 injection
DrugSubjects will receive subcutaneous injections of Zovaglutide (ZT002 Injection) once every two weeks.
ZT002 injection matching placebo
DrugSubjects will receive subcutaneous injections of ZT002 injection matching placebo once every two weeks.
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.
Effect of ZT002 plasma concentrations on heart rate (HR)
Measure the Effect of ZT002 plasma concentrations on HR
Effect of ZT002 plasma concentrations on QT interval corrected using Fridericia's formula (QTcF)
Measure the Effect of ZT002 plasma concentrations on QTcF;
Effect of ZT002 plasma concentrations on PR interval
Measure the Effect of ZT002 plasma concentrations on PR interval
Effect of ZT002 plasma concentrations on QRS complex duration
Measure the Effect of ZT002 plasma concentrations on QRS complex duration
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