A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing QL Biopharmaceutical Co.,Ltd

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Zovaglutide

    Drug

    Receive a single dose , SC

  • Zovaglutide

    Drug

    Receive a single dose , SC

  • Zovaglutide

    Drug

    Receive a single dose , SC

  • Zovaglutide

    Drug

    Receive a single dose , SC

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: A group (Mild Renal Impairment)Experimental treatment 1 intervention
Group B: B group (Moderate Renal Impairment)Experimental treatment 1 intervention
Group C: C group (Severe Renal Impairment)Experimental treatment 1 intervention
Group D: D group (Healthy Control)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t).

Time frame
Start of Treatment up to Day 50
2

Maximum Concentration of ZT002 (Cmax)

Time frame
Start of Treatment up to Day 50
3

Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞)

Time frame
Start of Treatment up to Day 50
4

Time to maximum concentration (Tmax)

Time frame
From baseline to Day 50

Secondary outcomes

Other outcomes

Sponsors and contacts

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