This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of RSS0343 following multiple oral doses in healthy subjects, as well as its effects on the QT/QTc interval.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
RSS0343 tablets, oral.
RSS0343 tablets placebo, oral.
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Incidence and severity of any adverse events (AEs).
Safety and tolerability.
Time frame: Evaluation was performed up to Day 28.
Maximum observed plasma concentration of RSS0343 at Day 1 (Cmax).
Pharmacokinetics (PK) indicator.
Time frame: Evaluation was performed up to Day 28.
Maximum observed plasma concentration of RSS0343 at steady state (Cmax,ss).
Pharmacokinetics (PK) indicator.
Time frame: Evaluation was performed up to Day 28.
Time to Cmax (Tmax).
Pharmacokinetics (PK) indicator.
Time frame: Evaluation was performed up to Day 28.
Time to Cmax,ss (Tmax,ss).
Pharmacokinetics (PK) indicator.
Time frame: Evaluation was performed up to Day 28.
Area under the concentration-time curve during a dosing interval (AUC0-tau).
Pharmacokinetics (PK) indicator.
Time frame: Evaluation was performed up to Day 28.
Area under the concentration-time curve from 0 to the last measurable time point after RSS0343 administration (AUC0-t).
Pharmacokinetics (PK) indicator.
Time frame: Evaluation was performed up to Day 28.
Area under the concentration-time curve from time 0 to infinity after RSS0343 administration (AUC0-inf).
Pharmacokinetics (PK) indicator.
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Time frame: Evaluation was performed up to Day 28.
Terminal elimination half-life of RSS0343 (t1/2).
Pharmacokinetics (PK) indicator.
Time frame: Evaluation was performed up to Day 28.
Apparent clearance of RSS0343 during multiple dosing with a dosing interval of time tau (CLss/F).
Pharmacokinetics (PK) indicator.
Time frame: Evaluation was performed up to Day 28.
Apparent volume of distribution during terminal elimination phase of RSS0343 at steady state (Vss/F).
Pharmacokinetics (PK) indicator.
Time frame: Evaluation was performed up to Day 28.
Cumulative amount of drug excreted in urine (Ae,urine).
Pharmacokinetics (PK) indicator.
Time frame: Evaluation was performed up to Day 28.
Cumulative percentage of dose recovered in urine (Fe,urine).
Pharmacokinetics (PK) indicator.
Time frame: Evaluation was performed up to Day 28.
Renal clearance of RSS0343 (CLr).
Pharmacokinetics (PK) indicator.
Time frame: Evaluation was performed up to Day 28.
Changes in the QTc interval corrected by the Fridericia method relative to baseline (ΔQTcF) (where applicable).
To evaluate the effects of RSS0343 on the QT/QTc interval in healthy subjects.
Time frame: Evaluation was performed up to Day 28.