This Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of HRS-4139 in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
HRS-4139 tablet.
HRS-4139 placebo.
Xiangya Hospital of Central South University
Changsha, Hunan, China
Adverse events (AEs)
Time frame: Evaluation was performed up to Day 36 or Day 72.
Serious Adverse events (SAEs)
Time frame: Evaluation was performed up to Day 36 or Day 72.
Plasma concentration of HRS-4139 in healthy participants
Time frame: Evaluation was performed up to Day 36 or Day 72.
Peak concentration (Cmax)
PK parameter.
Time frame: Evaluation was performed up to Day 36 or Day 72.
Time to peak concentration (Tmax)
PK parameter.
Time frame: Evaluation was performed up to Day 36 or Day 72.
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last)
PK parameter.
Time frame: Evaluation was performed up to Day 36 or Day 72.
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
PK parameter.
Time frame: Evaluation was performed up to Day 36 or Day 72.
Elimination half-life (t1/2)
PK parameter.
Time frame: Evaluation was performed up to Day 36 or Day 72.
Apparent clearance (CL/F)
PK parameter.
Time frame: Evaluation was performed up to Day 36 or Day 72.
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Apparent volume of distribution (Vd/F)
PK parameter.
Time frame: Evaluation was performed up to Day 36 or Day 72.
Incidence and time of onset of Anti drug antibody (ADA) positivity in healthy participants receiving HRS-4139
Time frame: Evaluation was performed up to Day 36 or Day 72.