This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, divided into two parts. The first part is a single-dose escalation study (Part1,SAD study phase), and the second part is a multiple-dose escalation study (Part2,MAD study phase). It's aimed to evaluate the safety, tolerability, and pharmacokinetics (PK) of ACT500 in healthy adult participants, and to explore possible metabolites and biomarkers of ACT500.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
72
Participants will receive a single ascending oral dose of ACT500 Tablets under fasting state on the first day in Part 1
Participants will receive placebo matched to ACT500 Tablets.
Participants will receive multiple ascending oral dose of ACT500 Tablets under fasting state once daily for 7 days in Part 2.
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Adverse Event(AE)
Time frame: SAD:Day1-8; MAD:Day1-22.
Serious Adverse Event
Time frame: SAD:Day1-8; MAD:Day1-22.
body temperature
Time frame: SAD:Day1-5; MAD:Day1,Day7-22.
respiration
Time frame: SAD:Day1-5; MAD:Day1,Day7-22.
pulse
Time frame: SAD:Day1-5; MAD:Day1,Day7-22.
heart rate
Time frame: SAD:Day1-5; MAD:Day1,Day7-22.
blood pressure
Time frame: SAD:Day1-5; MAD:Day1,Day7-22.
Physical Examination
Physical examination includes general condition, head and neck, lymph nodes, skin, chest, abdomen, and musculoskeletal system (including limbs and spine).
Time frame: SAD:Day1,Day3-8; MAD:Day1,Day3-22.
Number of Participants with 12-Lead Electrocardiogram Findings
Time frame: SAD:Day-1,Day5 ; MAD:Day-1,Day3,Day8and D14.
Number of Participants with Dynamic electrocardiogram(ECG)Findings
Time frame: SAD:Day1; MAD:Day1,Day7.
Number of Participants with Abnormal Laboratory Parameters Findings
Time frame: SAD:Day1-8; MAD:Day1-22.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will receive placebo matched to ACT500 Tablets.
Maximum concentration (Cmax)
Time frame: SAD:Day1-5;
Time to maximum concentration(Tmax)
Time frame: SAD:Day1-5;MAD:Day1-8
The area under the plasma concentration-time curve from the time of initial dosing to the time of the last measurable concentration point (AUC0-t)
Time frame: SAD:Day1-5;
The area under the plasma concentration-time curve from the time of initial dosing to infinity (AUC0-∞)
Time frame: SAD:Day1-5;
Apparent terminal elimination half-life (t1/2).
Time frame: SAD:Day1-5;
Clearance (CL/F)
Time frame: SAD:Day1-5;
Apparent Volume of Distribution (Vd/F)
Time frame: SAD:Day1-5;
Elimination Rate Constant(Kel)
Time frame: SAD:Day1-5;
Mean Residence Time(MRT)
Time frame: SAD:Day1-5;
Steady-state trough concentration(Cmin,ss)
Time frame: MAD:Day1-8;
Steady-state peak concentration(Cmax,ss)
Time frame: MAD:Day1-8;
Average steady-state plasma concentration(Cav,ss)
Time frame: MAD:Day1-8;
Elimination half-life(t1/2,ss)
Time frame: MAD:Day1-8;
Clearance (CLss/F)
Time frame: MAD:Day1-8;
Apparent Volume of Distribution (Vd/Fss)
Time frame: MAD:Day1-8;
Accumulation Index (RAC)
Time frame: MAD:Day1-8;
The area under the plasma concentration-time curve from the time of the last dose to the time of the last measurable concentration point (AUC0-t,ss)
Time frame: MAD:Day1-8;
The area under the plasma concentration-time curve within one dosing interval after the last dose (AUC0-τ)
Time frame: MAD:Day1-8;
The area under the plasma concentration-time curve extrapolated from the last dose to infinity (AUC0-∞,ss)
Time frame: MAD:Day1-8;
Coefficient of Fluctuation (DF)
Time frame: MAD:Day1-8;
Pharmacokinetic (PK):Plasma Concentrations of ACT500
Time frame: SAD:Day1-4;MAD:Day1-8;
Changes of biomarkers after single and multiple oral dosing compared to baseline
Time frame: SAD:Day1-5;MAD:Day1-8.