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Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function

ConditionObesity/Overweight
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGan & Lee Pharmaceuticals.

About this trial

This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal liver function and those with mild, moderate or severe liver insufficiency.

The study duration for each subject in this study is up to 50 days, including a screening period of up to 14 days (Day-14 to Day-1), an 8-day dosing/observation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects who fully understand the study contents, study procedures and possible risks, can follow the contraindications and restrictions specified in this protocol, and voluntarily sign the informed consent form.

Subjects (male or female) age ≥ 18 and ≤ 75 years at the time of signing the ICF.

Weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) of 19.0-32.0 kg/m2 (both inclusive).

Subjects with childbearing potential from signing the ICF to 8 weeks after the last dose have no family planning, are willing to adopt effective contraceptive measures and have no plans for sperm donation or egg donation; women of childbearing potential are not pregnant or lactating: they must have a negative pregnancy test at screening and have no unprotected sexual intercourse within 2 weeks before screening.

Disqualifiers

1. Subjects with an allergic constitution, including those with a history of severe drug hypersensitivity or allergy, and known to be allergic to the investigational drug or GLP-1 drugs or any component in the investigational drug (citrate, sodium chloride, disodium hydrogen phosphate, hydrochloric acid and sodium hydroxide).

Trial design

Design model

Parallel

Treatments tested in this trial

  • GZR18 injection

    Drug

    3 mg-Control group

  • GZR18 injection

    Drug

    3 mg-mild liver insufficiency

  • GZR18 injection

    Drug

    3 mg-moderate liver insufficiency

  • GZR18 injection

    Drug

    3 mg-severe liver insufficiency

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: GZR18 injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cmax:Maximum plasma concentration.

Time frame
through study completion, an average of 36 days
2

AUC0-last:Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.

Time frame
through study completion, an average of 36 days
3

AUC0-inf:Area under the plasma concentration-time curve at 0 h to infinity after a single dose.

Time frame
through study completion, an average of 36 days

Secondary outcomes

1

AUC0-336 h：Area under the plasma concentration-time curve from time zero to 336 hours

Time frame
through study completion, an average of 36 days
2

Tmax:Time of Maximum Drug ConcentrationTime to Maximum aentration

Time frame
through study completion, an average of 36 days
3

TEAE：Treatment Emergent Adverse Event

Time frame
through study completion, an average of 36 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gan & Lee Pharmaceuticals.

Lead sponsor

Source ClinicalTrials.gov
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