A Multiple Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of SYHA1402 in Healthy Subjects.
This study consists of two parts: The objective of the food effect study (Part 1) is to investigate the effect of food on the pharmacokinetic profiles of SYHA1402 tablets under fed and fasted conditions following the oral administration of SYHA1402. The primary objective of the multiple doses study (Part 2) is to investigate safety, tolerability and Pharmacokinetics of SYHA1402 in healthy subjects following oral administration of Multiple rising doses. Secondary objectives are the exploration of pharmacokinetics (PK) following multiple oral doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
42
in either a fasted state or with a meal
SYHA1402 25mg, oral tablets
Matching placebo tablets
Effect of food on the pharmacokinetic(Cmax)
Effect of food on the pharmacokinetic profile of SYHA1402 based on maximum observed plasma concentration (Cmax) (Part 1).
Time frame: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
Effect of food on the pharmacokinetic(AUC0-inf)
Effect of food on the pharmacokinetic profile of SYHA1402 based on AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity) (Part 1).
Time frame: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
Effect of food on the pharmacokinetic(AUC0-t)
Effect of food on the pharmacokinetic profile of SYHA1402 based on AUC0-t (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of last measurable concentration) (Part 1).
Time frame: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
Safety and tolerability of multiple doses of SYHA1402 administered orally will be assessed (Part2).
incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams
Time frame: up to 5 days after the last dose
Safety and tolerability of SYHA1402 administered orally in fed and fasted conditions will be assessed (Part1)
incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams
Time frame: up to 4 days after the last dose
AUC0-t(Part2)
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SYHA1402 50mg, oral tablets
Matching placebo tablets
SYHA1402 150mg, oral tablets
Matching placebo tablets
Rate and Extent of Absorption SYHA1402 by Assessment of the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
AUC0-inf(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
Cmax(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the maximum measured concentration of the analyte in plasma
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
Tmax(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the Time to Reach Maximum Observed Concentration
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
t1/2z(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Terminal Elimination Half-life
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
CL/F(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Clearance
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
Vz/F(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Volume of Distribution
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
Rac(AUC)(Part2)
Rate and Extent of Absorption of SYHA1402 by Assessment of the Accumulation Ratio
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
Rac(Cmax) (Part2)
Rate and Extent of Absorption of AZD7986 by Assessment of the Accumulation Ratio for Cmax
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
The assessment of the dose-proportionality based on Cmax (Part2)
The assessment of the dose-proportionality in the plasma pharmacokinetics (Cmax) of SYHA1402
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
The assessment of the dose-proportionality based on AUC (Part2)
The assessment of the dose-proportionality in the plasma pharmacokinetics (AUC) of SYHA1402
Time frame: Predose and multiple timepoints up to 24 hours after the last dose