This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HRS-6257 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The incidence and severity of adverse events
Time frame: from ICF signing date to Day 14 or Day 21 or Day 27
AUC of HRS-6257
Time frame: 0 hour to 72 hour after administration
Cmax of HRS-6257
Time frame: 0 hour to 72 hour after administration
Tmax of HRS-6257
Time frame: 0 hour to 72 hour after administration
t1/2 of HRS-6257
Time frame: 0 hour to 72 hour after administration
CL/F of HRS-6257
Time frame: 0 hour to 72 hour after administration
Vz/F of HRS-6257
Time frame: 0 hour to 72 hour after administration
Pain tolerance time for the Cold Pain Test
Time frame: Day 1 to Day 1 or Day 14
Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
Time frame: from ICF signing date to Day 14
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