This is a randomized, double-blind, dose-escalating, placebo controlled, Phase I study to evaluate the safety, pharmacokinetics and pharmacodynamics of DDO-3055 in healthy volunteers and patients with chronic kidney disease. 48 healthy volunteers will be enrolled in Part A, and 18 patients with chronic kidney disease will be enrolled in Part B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
54
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Adverse Events(AEs) and Serious Adverse Events (SAEs)
Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events
Time frame: from informed consent form signature to the end of the study (up to 14 days)
Area under the plasma concentration versus time curve (AUC) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Maximum observed serum concentration (Cmax) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Time to maximum observed serum concentration (tmax) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Time to elimination half-life (t1/2) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Apparent volume of distribution after non-intravenous administration (V/F) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Renal clearance of the drug from plasma (CLR) of DDO-3055
Time frame: Pre-dose to 72 hours after dose administration
Changes in red blood cell count relative to baseline
Time frame: up to 14 days
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Changes in reticulocyte count relative to baseline
Time frame: up to 14 days
Changes in hemoglobin relative to baseline
Time frame: up to 14 days
Changes in endogenous erythropoietin relative to baseline
Time frame: up to 14 days