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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LP-168 tablet | Experimental | After confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet. |
|
| LP-168 Placebo tablet | Placebo Comparator | After confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP-168 tablet | Drug | Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0 | 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 | 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 | 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 | Up to 96 hours post last dose | |
| PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168 | Up to 96 hours post last dose | |
| PK As Assessed By Terminal Half-life (t1/2) of LP-168 | Up to 96 hours post last dose | |
| PK As Assessed By Terminal Vd/F of LP-168 | Up to 96 hours post last dose | |
| PK As Assessed By Terminal CL/F of LP-168 | Up to 96 hours post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| PD as Assessed by elisa analysis the proportion of LP-168 occupied kinase at scheduled timepoints pre-dose and post-dose | Up to 48 hours post last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinliang Chen, PhD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| LP-168 Placebo tablet | Drug | 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 |
|
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009188 | Myelitis, Transverse |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |