A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAusper Biopharma Co., Ltd.

About this trial

A clinical study evaluating the pharmacokinetic characteristics and safety of AHB-137 injection in participants with mild to moderate liver dysfunction and those with normal liver function.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Voluntarily participate in the study, sign an informed consent form before the study and be able to complete the study according to the requirements of the protocol;

At the time of signing the informed consent form, male or female participants aged 18-65 years (including threshold values);

Body mass index meets the criteria;

Take effective contraceptive measures as required;

Disqualifiers

Diagnosed or suspected liver cancer participants who have undergone liver transplantation;

History of vasculitis or presence of signs and symptoms of potential vasculitis or laboratory tests;

Unstable control of hypertension or diabetes, progressive nervous system disease, history of immune related extrahepatic diseases, and unstable cardiac function;

Participants with a history of malignant tumors or undergoing malignant tumor assessment;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AHB-137 injection

    Drug

    Single use subcutaneous injection

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: Part1: Child-Pugh B groupExperimental treatment 1 intervention
Group B: Part2: Child-Pugh A groupExperimental treatment 1 intervention
Group C: Part1:Participants with normal liver function groupExperimental treatment 1 intervention
Group D: Part2:Participants with normal liver function groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax)

Time frame
Up to day 29
2

Key PK parameters of AHB-137 injection after single subcutaneous administration: area under the drug time curve from 0 to infinity (AUC)

Time frame
Up to day 29

Secondary outcomes

1

PK parameter: Area under the drug time curve from 0 to the last endpoint quantifiable concentration time point (AUCo- Last)

Time frame
Up to day 29
2

PK parameter: Area under the drug time curve from 0 to 24 hours (AUCo-24)

Time frame
Up to day 29
3

PK parameter: Area under the drug time curve from 0 to 168 hours (AUCo-168)

Time frame
Up to day 29
4

PK parameter: D8 blood concentration (C168)

Time frame
Up to day 29

Other outcomes

Sponsors and contacts

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