This study will investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of single oral administration of 5 mg, 15 mg, 20 mg and 25 mg of SSS17 compared with placebo, and evaluate the efficacy, safety, tolerance, pharmacokinetics and pharmacodynamics of multiple oral administration of 15 mg and 20 mg of SSS17 compared with placebo. In addition, the study will assess the effect of food on the pharmacokinetics of SSS17.
The study will enroll healthy volunteers from a single academic medical center in China. All participants will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures.The study will be divided into 3 parts. Part 1: Subjects will be allocated 2:8 to receive placebo or SSS17(it was only 2:2 in 5mg dose group),which will be administered by oral route with single dose. At each dose, tolerability, safety, PK and PD characteristics will be investigated. Part 2: Subjects will be allocated 2:8 to receive placebo or SSS17, which will be administered by oral route with multiple dose. At each cohort,tolerability, safety, PK and PD characteristics will be investigated. Part 3: The subjects will receive two cycles of treatment, one is given on an empty stomach, the other is given after a high-fat meal, with an interval of 15 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGPart 1: AEs
Assessment AEs by frequency and severity in the part 1
Time frame: Baseline up to Days 15
Part 1: Maximum plasma concentration (Cmax) of SSS17
Plasma samples will be collected and Cmax will be assessed in the part 1
Time frame: Up to 336 hours post-dose
Part 1: Area under the concentration-time curve (AUC) of plasma concentration of SSS17
Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 1
Time frame: Up to 336 hours post-dose
Part 1: Time-to-Cmax (Tmax) of SSS 17
Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 1
Time frame: Up to 336 hours post-dose
Part 1: Elimination terminal half-life (t1/2) of SSS17
Plasma samples will be collected and the t1/2 will be assessed in the part 1
Time frame: Up to 336 hours post-dose
Part 1: . Total amount of SSS17 excreted in urine over 72 hours (Ae0-72)
Urine sample will be collected at pre-specified intervals and Ae0-72 will be assessed in the part 1
Time frame: Up to 72 hours post-dose
Part 1: Fraction of SSS17 excretion during each collection interval (Fe0-72)
Urine sample will be collected at pre-specified intervals and Fe0-72 will be assessed in the part 1
Time frame: Up to 72 hours post-dose
Part 1: Renal clearance (CLR) of SSS17
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Urine sample will be collected at pre-specified intervals and CLR will be assessed in the part 1
Time frame: Up to 72 hours post-dose
Part 2: AEs
Assessment AEs by frequency and severity in the part 2
Time frame: Up to Days 33 or 57
Part 2: Steady state minimal concentration (Css_min) of SSS17
Plasma samples will be collected and Css\_min will be assessed in the part 2
Time frame: Up to Days 33 or 57
Part 2: Steady state maximum concentration (Css_max) of SSS17
Plasma samples will be collected and Css\_max will be assessed in the part 2
Time frame: Up to Days 33 or 57
Part 2: Steady state average concentration (Css_av) of SSS17
Plasma samples will be collected and Css\_av will be assessed in the part 2
Time frame: Up to Days 33 or 57
Part 2: Area under the concentration-time curve of plasma concentration of SSS17 within the interval of administration after reaching steady state (AUC0-τ)
Plasma samples will be collected and the AUC from zero to τ will be assessed
Time frame: Up to Days 33 or 57
Part 3: Maximum plasma concentration (Cmax) of SSS17
Plasma samples will be collected and Cmax will be assessed in the part 3
Time frame: Up to Days 44
Part 3: Area under the concentration-time curve (AUC) of plasma concentration of SSS17
Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 3
Time frame: Up to Days 44
Part 3: Time-to-Cmax (Tmax) of SSS 17
Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 3
Time frame: Up to Days 44
Part 3: Elimination terminal half-life (t1/2) of SSS17
Plasma samples will be collected and the t1/2 will be assessed in the part 3
Time frame: Up to Days 44
Part 1: EPO concentrations
Change of EPO concentrations from baseline following SSS17 in the part 1
Time frame: Up to 168 hours post-dose
Part 1: VEGF concentrations
Change of VEGF concentrations from baseline following SSS17 in the part 1
Time frame: Up to 168 hours post-dose
Part 1: Change of hepcidin from baseline
Change of serum hepcidin concentrations from baseline following SSS17 in the part 1
Time frame: Up to 168 hours post-dose
Part 1: Change of RTC from baseline
Change of RTC from baseline following SSS17 in the part 1
Time frame: Baseline up to Days 15
Part 1: Change of RBC from baseline
Change of RBC from baseline following SSS17 in the part 1
Time frame: Baseline up to Days 15
Part 1: Change of Hgb from baseline
Change of Hgb from baseline following SSS17 in the part 1
Time frame: Baseline up to Days 15
Part 2: EPO concentrations
Change of EPO concentrations from baseline following SSS17 in the part 2
Time frame: Up to Days 33 or 57
Part 2: VEGF concentrations
Change of VEGF concentrations from baseline following SSS17 in the part 2
Time frame: Up to Days 33 or 57
Part 2: Change of hepcidin from baseline
Change of serum hepcidin concentrations from baseline following SSS17 in the part 2
Time frame: Up to Days 33 or 57
Part 2: Change of RTC from baseline
Change of RTC from baseline following SSS17 in the part 2
Time frame: Baseline up to Days 33 or 57
Part 2: Change of RBC from baseline
Change of RBC from baseline following SSS17 in the part 2
Time frame: Baseline up to Days 33 or 57
Part 2: Change of Hgb from baseline
Change of Hgb from baseline following SSS17 in the part 2
Time frame: Baseline up to Days 33 or 57
Part 3: AEs
Assessment AEs by frequency and severity in the part 3
Time frame: Up to Days 44
Part 3: EPO concentrations
Change of EPO concentrations from baseline following SSS17 in the part 3
Time frame: Up to Days 44
Part 3: VEGF concentrations
Change of VEGF concentrations from baseline following SSS17 in the part 3
Time frame: Up to Days 44
Part 3: Change of hepcidin from baseline
Change of serum hepcidin concentrations from baseline following SSS17 in the part 3
Time frame: Up to Days 44
Part 3: Change of RTC from baseline
Change of RTC from baseline following SSS17 in the part 3
Time frame: Baseline up to Days 44
Part 3: Change of RBC from baseline
Change of RBC from baseline following SSS17 in the part 3
Time frame: Baseline up to Days 44
Part 3: Change of Hgb from baseline
Change of Hgb from baseline following SSS17 in the part 3
Time frame: Baseline up to Days 44