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The purpose of this study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers.
This is an open-label study in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of four formulations of LY03009 (F1, F2, F3, F4) after a single intramuscular injection.
Approximately 40 healthy subjects are planned to be enrolled in this study and assigned to four cohorts (F1, F2, F3, F4) sequentially, 10 subjects per group at a fixed dose of 112 mg for F1~F3 and 224 mg for F4. Each subject will receive only one dose in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation 1 | Experimental | a single dose of LY03009 F1 |
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| Formulation 2 | Experimental | a single dose of LY03009 F2 |
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| Formulation 3 | Experimental | a single dose of LY03009 F3 |
|
| Formulation 4 | Experimental | a single dose of LY03009 F4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03009 F1 | Drug | a single dose of LY03009 F1 |
| |
| LY03009 F2 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | Frequency of adverse events. Apply to cohort F1, cohort F2 and cohort F3. | From screening up to day 98 |
| Frequency of adverse events | Frequency of adverse events. Apply to cohort F4. | From screening up to day 161 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum (peak) plasma concentration (Cmax) of LY03009 | Maximum (peak) plasma concentration (Cmax) of LY03009. Apply to cohort F1, cohort F2 and cohort F3. | From screening up to day 98 |
| Maximum (peak) plasma concentration (Cmax) of LY03009 |
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Inclusion Criteria:
To participate in the study, subjects must meet all of the following inclusion criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Molga | CMAX Clinical Research Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX clinical Research Pty Ltd | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Drug |
a single dose of LY03009 F2 |
|
| LY03009 F3 | Drug | a single dose of LY03009 F3 |
|
| LY03009 F4 | Drug | a single dose of LY03009 F4 |
|
Maximum (peak) plasma concentration (Cmax) of LY03009. Apply to cohort F4
| From screening up to day 161 |
| Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009 | Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009.Apply to cohort F1, cohort F2 and cohort F3. | From screening up to day 98 |
| Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009 | Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009.Apply to cohort F4 | From screening up to day 161 |
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009 | Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009.Apply to cohort F1, cohort F2 and cohort F3. | From screening up to day 98 |
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009 | Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009. Apply to cohort F4 | From screening up to day 161 |
| Time to maximum plasma concentration (Tmax) of LY03009 | Time to maximum plasma concentration (Tmax) of LY03009. Apply to cohort F1, cohort F2 and cohort F3. | From screening up to day 98 |
| Time to maximum plasma concentration (Tmax) of LY03009 | Time to maximum plasma concentration (Tmax) of LY03009. Apply to cohort F4 | From screening up to day 161 |
| Terminal elimination half-life (t1/2) of LY03009 | Terminal elimination half-life (t1/2) of LY03009. Apply to cohort F1, cohort F2 and cohort F3. | From screening up to day 98 |
| Terminal elimination half-life (t1/2) of LY03009 | Terminal elimination half-life (t1/2) of LY03009.Apply to cohort F4 | From screening up to day 161 |
| Apparent clearance (CL/F) of LY03009 | Apparent clearance (CL/F) of LY03009. Apply to cohort F1, cohort F2 and cohort F3. | From screening up to day 98 |
| Apparent clearance (CL/F) of LY03009 | Apparent clearance (CL/F) of LY03009. Apply to cohort F4 | From screening up to day 161 |
| Apparent volume of distribution (Vz/F) of LY03009 | Apparent volume of distribution (Vz/F) of LY03009. Apply to cohort F1, cohort F2 and cohort F3. | From screening up to day 98 |
| Apparent volume of distribution (Vz/F) of LY03009 | Apparent volume of distribution (Vz/F) of LY03009. Apply to cohort F4 | From screening up to day 161 |
| Terminal elimination rate constant (λz) of LY03009 | Terminal elimination rate constant (λz) of LY03009. Apply to cohort F1, cohort F2 and cohort F3. | From screening up to day 98 |
| Terminal elimination rate constant (λz) of LY03009 | Terminal elimination rate constant (λz) of LY03009. Apply to cohort F4 | From screening up to day 161 |
| Mean residence time (MRT) of LY03009 | Mean residence time (MRT) of LY03009. Apply to cohort F1, cohort F2 and cohort F3. | From screening up to day 98 |
| Mean residence time (MRT) of LY03009 | Mean residence time (MRT) of LY03009. Apply to cohort F4 | From screening up to day 161 |
| Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009 | Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009. Apply to cohort F1, cohort F2 and cohort F3. | From screening up to day 98 |
| Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009 | Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009. Apply to cohort F4 | From screening up to day 161 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |