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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Single use subcutaneous injection
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax)
Time frame: Up to day 29
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
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
PK parameter: Area under the drug time curve from 0 to 24 hours (AUCo-24)
Time frame: Up to day 29
PK parameter: Area under the drug time curve from 0 to 168 hours (AUCo-168)
Time frame: Up to day 29
PK parameter: D8 blood concentration (C168)
Time frame: Up to day 29
PK parameter: peak time (Tmax)
Time frame: Up to day29
Safety indicators
The proportion of participants who experienced all adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESIs) during the treatment period after a single subcutaneous administration of AHB-137 injection; And laboratory tests, 12 lead ECG, and changes in vital signs compared to baseline.
Time frame: Up to day 29
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