This is double-blind,randomized, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety, tolerability and drug-drug interaction of RAY1216, and the effect of food on RAY1216 Pharmacokinetics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
RAY1216 dose 1 or Placebo
RAY1216 dose 2 or Placebo
RAY1216 dose 3 or Placebo
The First Hospital of Jilin University
Jilin City, China
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in single ascending dose
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Time frame: Day 1 to Day 5
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in multiple ascending dose
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Time frame: Day 1 to Day 9
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in DDI part
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Time frame: Day 1 to Day 15
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in food effect part
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Time frame: Day 1 to Day 21
To determine the effect of food on the PK of RAY1216 single dose(Cmax)
Time frame: Day 1 to Day 21
To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(Cmax)
Time frame: Day 1 to Day 15
To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmax)
Time frame: Day 1 to Day 9
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RAY1216 dose 4 \&ritonavir or Placebo
RAY1216 dose 5 or Placebo
RAY1216 dose 6 or Placebo
RAY1216 dose 7 or Placebo
RAY1216 dose 8 or Placebo
RAY1216 dose 9 or Placebo with high fat meal
RAY1216 dose 10 or Placebo with high fat meal
To determine the effect of food on the PK of RAY1216 single dose(AUC0-∞)
Time frame: Day 1 to Day 21
To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(AUC0-∞)
Time frame: Day 1 to Day 15
To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmin)
Time frame: Day 1 to Day 9