This is a Phase I trial designed to evaluate the impact of renal impairment on the efficacy and safety of the drug by comparing pharmacokinetic (PK) parameters and pharmacodynamic (PD) markers after a single subcutaneous injection of RG002C0106 between trial participants with normal renal function and those with mild to moderate renal impairment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
Subcutaneous (SC) single dose 200mg
Calculate the pharmacokinetic (PK) parameters:Cmax
Time frame: From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:Tmax
Time frame: From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:AUC0-12h , AUC0-24h , AUC0-t, AUC0-∞
Time frame: From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:t½
Time frame: From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:Vd/F
Time frame: From enrollment to the end of treatment at 4 days
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug.
Time frame: up to 169 days
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