This is a phase Ⅰ,single-center, randomized, double-blinded, placebo-controlled, single ascending dose trial of SY-008 in healthy subjects.
This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic / pharmacodynamic study of a single oral SY-008 capsule for Chinese healthy subjects. Plan to screening total of 54 healthy subjects , dividing them into 6 dose groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
The study will be initiated in healthy subjects at a 2-mg dose that is expected to have minimal pharmacologic effect. Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 6, 12, 18, 24, 30mg successively. The increment of the dose escalation may be reduced, a lower dose may be administered following data review.
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Time frame: 7 days
area under curve (AUC) of SY-008 following oral administration of single ascending dose
to measure the study drug concentration in blood samples to be collected after drug administration.
Time frame: 3 days
Cmax of SY-008 following oral administration of single ascending dose
to measure the study drug concentration in blood samples to be collected after drug administration.
Time frame: 3 days
T1/2 of SY-008 following oral administration of single ascending dose
to measure the study drug concentration in blood samples to be collected after drug administration.
Time frame: 3 days
CL/F (Clearance rectified) of SY-008 following oral administration of single ascending dose
to measure the study drug concentration in blood samples to be collected after drug administration.
Time frame: 3 days
glucose levels following single dose of SY-008
FPG AUC
Time frame: 24 hours
insulin secretion following single dose of SY-008
insulin changes
Time frame: 3 days
C-peptide secretion following single dose of SY-008
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C-peptide change
Time frame: 6 hours