A Study of LP-168 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LP-168 Following Single and Multiple Oral Administration to Healthy Volunteers

Conditions
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Multiple Sclerosis, NMO Spectrum Disorder

Intervention / Treatment
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* Drug: LP-168 tablet
* Drug: LP-168 Placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects have no history of serious digestive system, central nervous system, cardiovascular system, kidney, respiratory system, metabolism and endocrine, skeletal and muscular system, blood system disease and cancer Subjects (including partners) are willing to take effective contraception measures during study and within 3 months after last dose Male and female healthy subjects aged 18 to 55 years old Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg Subjects able to understand and comply with study requirements Willing to sign the informed consent Exclusion Criteria: Abnormal vital signs, physical examination or laboratory tests with clinical significance Abnormal ECG or echocardiography with clinical significance Hepatitis B virus, Hepatitis C virus, HIV and syphilis test positive. COVID-19 DNA positive. Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug Subjects who have consumed diets that may alter the activity of liver metabolic enzymes within 7 days before administration the study drug Subjects who have consumed tea or alcohol-containing food product within 24hrs before administration the study drug Subjects who have a history of dysphagia or condition may affect drug absorption, distribution, metabolism and excretion Female subjects are breastfeeding or pregnant Subjects who have a history of drug/ alcohol/ tobacco abuse Subjects who have had a blood donation or massive blood loss within three months before screening; or had surgery within six months before screening Subjects who have participated in other clinical trial within three months before screening Subjects have special dietary requirements or cannot tolerate a standard meal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LP-168 tablet<br>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. | Drug: LP-168 tablet<br>* Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration<br>* Other names: NWP-775;|
| Placebo Comparator: LP-168 Placebo tablet<br>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. | Drug: LP-168 Placebo tablet<br>* 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<br>* Other names: NWP-775 Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |