A Study to Investigate the Effects of Zovaglutide (ZT002 Injection) on QTc Interval in Healthy Adults

Korábbi kezelés

• 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).
• Medical history of hypoglycemia within 6 months before screening;
• ECG findings exceeding thresholds at screening or prior to randomization: PR interval >220 ms, QRS duration >110 ms, heart rate (HR) <50 bpm or >100 bpm, QTcF ≥450 ms; or presence of any ECG abnormalities deemed clinically significant by the investigator.
• Subjects who have previously undergone gastric bariatric surgery or other weight-loss surgeries, or who plan to receive weight-loss surgery, liposuction, abdominal lipectomy, or other procedures with substantial impacts on body weight during the study.
• Use of weight-altering medications or therapies within 3 months prior to screening.

Más betegség

• 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.
• History of acute or chronic pancreatitis;

Laborértékek

• 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.
• Glycated hemoglobin (HbA1c) ≥ 6.5% or fasting plasma glucose ≥ 7.0 mmol/L at screening;
• Aspartate aminotransferase > 2 × upper limit of normal (ULN), Alanine aminotransferase > 2 × ULN,
• Alkaline phosphatase total bilirubin > 1.5 × ULN;
• Administration of any medications known to prolong QT/QTc interval, alter heart rate, or carry risks of torsades de pointes (TdP) within 4 weeks prior to screening

Egyéb

• Pregnant or lactating women, or subjects with a positive pregnancy test result at screening/baseline

• 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);