Multiple Sclerosis, NMO Spectrum Disorder
Conditions
Brief summary
This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of LP-168 in healthy human volunteers.
Detailed description
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.
Interventions
DRUGLP-168 tablet
Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
DRUGLP-168 Placebo tablet
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
Sponsors
Guangzhou Lupeng Pharmaceutical Company LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK As Assessed By Terminal CL/F of LP-168 | Up to 96 hours post last dose |
| 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 |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed