This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of LP-168 in healthy human volunteers.
This study will enroll 70 healthy subjects, will set 4 SAD and 3 MAD dose cohorts, with 10 subjects in each dose cohort. Subjects will be assigned to L-168 or placebo group by ratio of 8:2 in each cohort. Sentinel subjects will be used in each dose cohort during the single dose phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
LP-168 placebo tablets contain excipients for LP-168 tablets, but do not contain the active ingredients of the drug, and are used for comparison in clinical trials with the same usage and dosage as LP-168 tablets
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0
Time frame: From the first dose of the study drug to 5 days after last dose
Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0
Time frame: From the first dose of the study drug to 5 days after last dose
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) of LP-168
Time frame: Up to 96 hours post last dose
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time of The Last Quantifiable Concentration (AUC0-t) Of LP-168
Time frame: Up to 96 hours post last dose
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168
Time frame: Up to 96 hours post last dose
PK As Assessed By Terminal Half-life (t1/2) of LP-168
Time frame: Up to 96 hours post last dose
PK As Assessed By Terminal Vd/F of LP-168
Time frame: Up to 96 hours post last dose
PK As Assessed By Terminal CL/F of LP-168
Time frame: Up to 96 hours post last dose
PD as Assessed by elisa analysis the proportion of LP-168 occupied kinase at scheduled timepoints pre-dose and post-dose
Time frame: Up to 48 hours post last dose
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