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This is a single-center, randomized, double-blind, placebo-controlled, ascending single oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects.
The study will set 2.5mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg and 100mg, a total of 8 dose groups. Qualified subjects were enrolled in site at D-1 ( 1 day before administration ) and randomized.The subjects should fast for at least 10 hours before medication administration, with no restrictions on water intake. The subjects will be required to orally take LY03020 or a placebo on an empty stomach upon waking on D1 (the day of medication administration). From D1 to D7, they will undergo safety assessments and PK biological sample collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY03020 | Experimental | Subjects will take single-dose LY03020 on Day 1 |
|
| Placebo | Sham Comparator | Subjects will take single-dose Placebo on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03020 | Drug | LY03020 for one single dose |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (AEs) | Percentage of adverse events | up to144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of LPM787000048 in plasma | Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated. | up to144 hours |
| Time to maximum observed concentration (Tmax) of LPM787000048 in plasma |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitatively determine the concentration of LPM787000048 and major metabolites (if applicable) in urine and calculate the cumulative excretion ratio in urine. | One dose group will be selected for metabolite identification. | up to144 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Wang | Beijing AnDing Hospital Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing AnDing Hospital Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug | Placebo for one single dose |
|
|
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated. |
| up to144 hours |
| Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma | Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated. | up to144 hours |
| Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma | Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated. | up to144 hours |
| Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma | Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated. | up to144 hours |
| Apparent volume of distribution(Vz/F) of LPM787000048 in plasma | Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated. | up to144 hours |
| Apparent total body clearance (CL/F) of LPM787000048 from plasma | Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated. | up to144 hours |