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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
AHB-137 injection
DrugSingle use subcutaneous injection
Treatment groups
Trial outcomes
Primary outcomes
Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax)
Key PK parameters of AHB-137 injection after single subcutaneous administration: area under the drug time curve from 0 to infinity (AUC)
Secondary outcomes
PK parameter: Area under the drug time curve from 0 to the last endpoint quantifiable concentration time point (AUCo- Last)
PK parameter: Area under the drug time curve from 0 to 24 hours (AUCo-24)
PK parameter: Area under the drug time curve from 0 to 168 hours (AUCo-168)
PK parameter: D8 blood concentration (C168)
Sponsors and contacts
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