The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of SHR2150. will consist of 50 healthy subjects, 5 groups. The purpose of this part is to explore the safety, tolerability ,pharmacokinetics and pharmacodynamics of single doses of SHR2150 capsule in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
37
Single dose;SHR2150-dose 1 or Placebo-dose 1
Single dose;SHR2150-dose 2 or Placebo-dose 2
Single dose;SHR2150-dose 3 or Placebo-dose 3
Beijing youan Hospital,Capital medical university
Beijing, Beijing Municipality, China
The incidence and severity of treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: 9 DAYS for Group A.B.C.D.E
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma :[AUC0-last]
The area under the concentration-time curve from time zero (pre-dose) to last time.
Time frame: Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [AUC0-∞]
The area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.
Time frame: Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma :[t1/2]
Terminal Half-life
Time frame: Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma: [Tmax]
Time to Maximum Observed Concentration
Time frame: Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [Cmax]
Maximum Observed Plasma Concentration
Time frame: Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [CL/F]
Apparent clearance
Time frame: Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [Vz/F]
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Single dose;SHR2150-dose 4 or Placebo-dose 4
Single dose;SHR2150-dose 5 or Placebo-dose 5
Apparent volume of distribution
Time frame: Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [MRT]
Mean retention time
Time frame: Up to 96hours
Pharmacodynamics: Changes in Cytokines in Serum: interferon γ-inducible protein-10
Time frame: Up to 48hhours
Pharmacodynamics: Changes in Cytokines in Serum: Interferon-α
Time frame: Up to 48hours