The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
This is a three-part randomized, participant- and investigator blinded, placebo-controlled, multi-center, sequential study: single ascending dose (SAD) in healthy volunteers (HV), SAD in participants with chronic kidney disease (CKD) or diabetic chronic kidney disease (DKD) and multiple ascending dose (MAD) in participants with CKD or DKD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
Quotient Sciences Sea View
Miami, Florida, United States
RECRUITINGNovartis Investigative Site
Berlin, Germany
RECRUITINGNumber of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Time frame: From Day 1 (Part A) until Day 71 (Part C)
Maximum Observed Blood Concentrations (Cmax)
Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1).
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Time to reach maximum plasma concentration (Tmax)
Tmax is the time to reach maximum (peak) drug concentration after single-dose administration (time).
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Area under plasma concentration-time curve (AUClast)
AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast).
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Area under the plasma concentration-time curve (AUC[0-inf])
The AUC\[0-inf\] from time zero extrapolated to infinity (mass x time x volume-1).
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Terminal elimination half-life (T1/2)
T1/2 is the elimination half-life associated with the terminal slope.
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Apparent plasma clearance (CL/F)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CL/F is the apparent total body clearance of drug from plasma following extravascular administration.
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Apparent volume of distribution during terminal elimination phase (Vz/F)
Vz/F is the apparent volume of distribution during terminal elimination phase following extravascular administration.
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Drug accumulation ratio (Racc)
The ratio of accumulation of drug between the first and last dose, only for MAD part of the study.
Time frame: Part C: From pre-dose Day 1 until Day 71
Area under plasma concentration-time curve (AUCtau)
The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1) only for MAD part of the study.
Time frame: Part C: From pre-dose Day 1 until Day 71