An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal Function
A single-dose, open-label, Phase 1 study (HM-GLP2-102) was conducted to evaluate the impact of renal impairment (RI) on the pharmacokinetics (PK) of HM15912. This study aimed to assess the safety and PK profile of HM15912 at a minimum effective dose of 0.5 mg/kg, which was determined based on findings from a previous clinical study (HM-GLP2-101). The study was initially designed to be conducted in two parts. Part 1: An open-label, single-dose, parallel-group study to investigate the effect of RI on the PK, safety, and tolerability of HM15912 in subjects with severe RI and subjects with normal renal function as a control group. Part 2 (if applicable): An open-label, single-dose, parallel-group study to investigate the effect of RI on the PK, safety, and tolerability of HM15912 in subjects with moderate and mild RI.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Singe subcutaneous administration of HM15912 0.5 mg/kg
Orange County Research Center
Tustin, California, United States
Clinical Pharmacology of Miami
Miami, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
AMR Knoxville
Knoxville, Tennessee, United States
Maximum Serum Concentration (Cmax) of HM15912
Pharmacokinetic (PK) samples were collected for measurement of serum concentrations of HM15912 and analyzed using a fully validated method.
Time frame: Day 1 to 29 (Total duration: 29 days)
Area Under the Concentration-time Curve From Extrapolated to Infinity (AUC 0-infinity) of HM15912
PK samples were collected for measurement of serum concentrations of HM15912 and analyzed using a fully validated method.
Time frame: Day 1 to 29 (Total duration: 29 days)
Overall Summary of Treatment-emergent Adverse Events (TEAEs)
The number and percentages of subjects with TEAEs were to be summarized by cohort. A TEAE was defined as any AE that began, or worsened in severity, on or after the date of the first IP administration until the last follow-up visit.
Time frame: Day 1 up to Day 29
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