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This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for subsequent clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LPM3770164 | Experimental | LPM3770164 sustained-release tablets will be administrated with single dose from 0.5mg to 60mg |
|
| Placebo | Placebo Comparator | LPM3770164 sustained release tablet simulant will be administrated with single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPM3770164 sustained release tablet | Drug | LPM3770164 sustained release tablet will be administrated orally single-dose on day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse effects | Number of participants with treatment-emergent adverse effects will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment. | from baseline to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | from baseline to day 15 | |
| Time to maximum observed concentration (Tmax) | from baseline to day 15 | |
| Area under the concentration-time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| hufang Li, Doctor | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | China |
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| LPM3770164 sustained release tablet simulant | Drug | LPM3770164 sustained release tablet simulant will be administrated orally single-dose on day 1 |
|
|
| from baseline to day 15 |
| Clearance (CL) | from baseline to day 15 |
| Half-life (t1/2) | from baseline to day 15 |
| Mean Residence Time (MRT) | from baseline to day 15 |
| Haematology | baseline, day 3, day 8, day 15, day 28 |
| Blood Chemistry | baseline, day 3, day 8, day 15, day 28 |
| Urinalysis | baseline, day 15, day 28 |
| Coagulation | baseline, day 15, day 28 |
| Body Temperature | baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28 |
| Respiratory Rate | baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28 |
| Blood Pressure | baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28 |
| Pulse Rate | baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28 |
| Physical Examination | baseline, day 15, day 28 |
| 12 lead electrocardiogram corrected QT interval | baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28 |
| Simpson-Angus Rating Scale (SAS) | baseline, day 3, day 28 |
| Barnes Akathisia Rating Scale (BARS) | baseline, day 3, day 28 |
| Abnormal Involuntary Movement Scale (AIMS) | baseline, day 3, day 28 |
| Stanford Sleepiness Scale (SSS) | baseline, day 3, day 28 |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D000071057 | Tardive Dyskinesia |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004409 | Dyskinesia, Drug-Induced |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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