This is a phase 1b, partial-blind (Sponsor unblinded), randomized, multicenter, placebo-controlled study. The primary objective of this study is to evaluate the pharmacokinetics (PK) of CSL300 after single and multiple doses in Chinese participants with end stage kidney disease (ESKD) undergoing dialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Peking University People's Hospital
Beijing, China
RECRUITINGArea Under the Concentration-time (AUC) Curve of CSL300 Over 1 Dosing Interval After Multiple Doses (AUC0-tau,MD)
Time frame: Day 85 up to Day 113
Trough Concentration at Steady State (Ctrough,ss)
Time frame: Up to Day 141
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Event of Special Interests (AESIs)
The following adverse events (AEs) are defined as AESIs: relevant infections (tuberculosis, herpes simplex virus, herpes zoster, human papillomavirus, human immunodeficiency virus, hepatitis B, hepatitis C, and invasive fungal infections), and demyelinating disorders.
Time frame: Up to Day 225 (End of Study [EoS])
Percentage of Participants With TEAEs, SAEs, and AESIs
The following AEs are defined as AESIs: relevant infections (tuberculosis, herpes simplex virus, herpes zoster, human papillomavirus, human immunodeficiency virus, hepatitis B, hepatitis C, and invasive fungal infections), and demyelinating disorders.
Time frame: Up to Day 225 (EoS)
Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Test Results
Laboratory assessments will include hematology parameters such as white blood cells (leukocytes), neutrophils, and platelets; chemistry evaluations including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin; a lipid panel comprising total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides; and immunogenicity testing.
Time frame: At Baseline and up to Day 225 (EoS)
Number of Participants With Antidrug Antibodies
The detection of antibodies to CSL300 will be performed using a validated immunoassay method.
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Time frame: At Days 1, 29, 85, and 169
Maximum Observed Concentration (Cmax) of CSL300
Time frame: Up to Day 169
Area Under the Concentration-Time Curve From Time 0 to Day 28 (AUC0-28d) of CSL300
Time frame: Up to Day 28
Trough Concentration (Ctrough) of CSL300
Time frame: Up to Day 141
Time to Reach Cmax (Tmax) of CSL300
Time frame: Up to Day 85
Change From Baseline on log-scale High-Sensitivity C-reactive Protein (hs-CRP)
Time frame: At Baseline, Week 12, and Week 24
Plasma Interleukin-6 (IL-6) Free and Total Levels
Time frame: At Weeks 12 and 24