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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBeijing QL Biopharmaceutical Co.,Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • ZT002 injection
  • ZT002 injection matching placebo

Treatment groups

40 Participants
are divided into 2 treatment groups