Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Safety, Tolerability, Pharmacokinetic and Food Effect Study of HEC122505MsOH Tablets in Healthy Subjects
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of HEC122505MsOH Tablets(pilot trial arm) | Experimental | Healthy subjects receive single dose of tablets HEC122505MsOH |
|
| Single dose of HEC122505MsOH Tablets(Part 1, Cohort 1) | Experimental | Healthy subjects receive single dose of HEC122505MsOH or matching placebo |
|
| Single dose of HEC122505MsOH Tablets(Part 1, Cohort 2) | Experimental | Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo |
|
| Single dose of HEC122505MsOH Tablets(Part 1, Cohort 3,Fed/Fasting) | Experimental | Following an overnight fast of at least 10 hours, a single dose of HEC585 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. |
|
| Single dose of HEC122505MsOH Tablets(Part 1, Cohort 4) | Experimental | Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC122505MsOH | Drug | Part2:Mulltiple doses once daily, up to 8 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Adverse Events (AEs) | To investigate the safety and tolerability of HEC122505MsOH by assessment of AEs (non-serious and serious) following administration of oral HEC122505MsOH tablets | Part 1:up to 6 days; Part 2: up to 13 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Plasma Concentration(Cmax) | up to 120 hours |
| AUC | Area Under the Curve(AUC) | up to 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| MAO-B | Monoamine Oxidase B(MAO-B) | up to 120 hours |
| MAO-A | Monoamine Oxidase A(MAO-A) | up to 120 hours |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Single dose of HEC122505MsOH Tablets(Part 1,Cohort 5) | Experimental | Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo |
|
| Single dose of HEC122505MsOH Tablets(Part 1, Cohort 6) | Experimental | Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo |
|
| Multiple doses of HEC122505MsOH Tablets(Part 2, Cohort 1) | Experimental | Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo |
|
| Multiple doses of HEC122505MsOH Tablets(Part 2, Cohort 2) | Experimental | Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo |
|
| Multiple doses of HEC122505MsOH Tablets(Part 2, Cohort 3) | Experimental | Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo |
|
| Tmax Tmax | Maximum Peak Time(Tmax) | up to 120 hours |
| t½ | Elimination Half-life(t½) | up to 120 hours |
| MRT | Mean Residence Time(MRT) | up to 120 hours |
| CL/F | Apparent Clearance(CL/F) | up to 120 hours |
| Vz/F | Apparent Volume of Distribution(Vz/F) | up to 120 hours |
| Kel | Elimination Rate Constant(Kel) | up to 120 hours |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |