The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of HRS-5765 in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
HRS-5765 tablet, specified dose on specified day.
HRS-5765 tablet placebo, specified dose on specified day.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGIncidence of adverse event (AE)
Safety parameter.
Time frame: Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).
Incidence of serious adverse event (SAE)
Safety parameter.
Time frame: Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).
Area under the concentration-time curve (AUC)
PK parameter of HRS-5765.
Time frame: Day 1-Day 18.
Maximum plasma concentration (Cmax)
PK parameter of HRS-5765.
Time frame: Day 1-Day 18.
Time to maximum plasma concentration (Tmax)
PK parameter of HRS-5765.
Time frame: Day 1-Day 18.
Apparent clearance (CL/F)
PK parameter of HRS-5765.
Time frame: Day 1-Day 18.
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