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This is a phase 1,randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY03017 | Experimental | Ascending single oral doses of LY03017 in healthy adult subjects |
|
| Placebo | Placebo Comparator | LY03017-Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03017 | Drug | single dose, administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | up to 216 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of LPM526000133 in plasma | up to 216 hours | |
| Time to maximum observed concentration (Tmax) of LPM526000133 in plasma | up to 216 hours | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huafang Li | Contact | +8618017311256 | 021-34773107 | lhlh_5@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | China |
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| LY03017-Placebo | Drug | single dose, administered orally |
|
| The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma |
| up to 216 hours |
| Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma | up to 216 hours |
| Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma | up to 216 hours |
| ID | Term |
|---|---|
| D006212 | Hallucinations |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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