About this trial
This study is a single-dose, open-label, parallel design phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of ZT002 Injection in participants with different degrees of renal insufficiency and matched participants with normal renal function.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
Male or female, age between 18 - 75 years (both inclusive) at the time of signing of the informed consent.
Body mass index (BMI) 19.0 - 32.0 kg/m²(both inclusive). Body weight ≥50 kg for male participants and ≥45 kg for female participants.
Diagnosed as stable, chronic renal disease for at least 3 months.
Disqualifiers
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 depression/anxiety disorder, or prior diagnosis of moderate-to-severe anxiety/depressive state, or history of severe psychiatric disorders;
Those with any type of treated or untreated malignancy (whether cured or not) within 5 years before screening or during the baseline period (except basal cell carcinoma of the skin)
Trial design
Parallel
Treatments tested in this trial
Zovaglutide
DrugReceive a single dose , SC
Zovaglutide
DrugReceive a single dose , SC
Zovaglutide
DrugReceive a single dose , SC
Zovaglutide
DrugReceive a single dose , SC
Treatment groups
Trial outcomes
Primary outcomes
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t).
Maximum Concentration of ZT002 (Cmax)
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞)
Time to maximum concentration (Tmax)
Sponsors and contacts
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