A Single-Dose Pharmacokinetic Study of HRS-4729 Injection in Healthy Participants and Patients With Renal Impairment

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

This study aims to evaluate the pharmacokinetic effects of a single dose of HRS-4729 injection in participants with mild, moderate, and severe renal impairment, with 8 participants enrolled in each renal impairment group and 8 healthy participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provide written informed consent prior to any study-related procedures, and have a full understanding of the study content, procedures, and potential adverse events.

Be aged 18 to 65 years (inclusive), of either sex.

Have a body mass index (BMI) between 19 and 40 kg/m² (inclusive).

Glomerular filtration rate (absolute eGFR) must meet the relevant requirements and criteria specified in the protocol.

Disqualifiers

Have a history of significant abnormal gastric emptying, severe gastrointestinal disease, or gastrointestinal surgery (except gastrointestinal polypectomy), as assessed by the investigator to be unsuitable for participation.

Have a history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2), or a history of pancreatitis or symptomatic cholelithiasis.

Have a history of malignancy in any organ system within the past 5 years, regardless of evidence of local recurrence or metastasis, with the exception of cured localized basal cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the prostate.

Have undergone any surgery within 6 months prior to dosing, or plan to undergo surgery during the study period (excluding gastrointestinal polypectomy).

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-4729

    Drug

    Each subject will receive a single subcutaneous dose of HRS-4729 injection solution.

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: Group A: control group, comprising healthy Participants with normal renal function;Experimental treatment 1 intervention
Group B: Group B: comprise Participants with mild renal impairment;Experimental treatment 1 intervention
Group C: Group C: comprise Participants with moderate renal impairment;Experimental treatment 1 intervention
Group D: Group D: comprise Participants with severe renal impairment;Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cmax

Time frame
assessed up to approximately 4 weeks post-dose;
2

AUC0-t

Time frame
assessed up to approximately 4 weeks post-dose
3

AUC0-inf.

Time frame
assessed up to approximately 4 weeks post-dose

Secondary outcomes

1

Tmax

Time frame
assessed up to approximately 4 weeks post-dose
2

CL/F

Time frame
assessed up to approximately 4 weeks post-dose
3

Vz/F

Time frame
assessed up to approximately 4 weeks post-dose
4

t1/2

Time frame
assessed up to approximately 4 weeks post-dose

Other outcomes

Sponsors and contacts

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