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The purpose of the study is to evaluate the safety, tolerability after administration of single dose or multiple doses, and the pharmacokinetics (PK) of single and multiple doses of JX2105 in healthy study participants.
Overall design:
This study is divided into 3 parts: Part 1: single-dose escalation study (SAD); Part 2: multiple-dose escalation study (MAD); Part 3: food-effect study (FE). Part 1 includes 7 cohorts; Part 2 includes 2~3cohorts; and Part 3 food effect study will conduct on 1 dose strength to evaluate the effect of food intake on pharmacokinetic/pharmacodynamics of JX2105 and its metabolites. The doses of part 2 and 3 will be designed according to the PK parameters from Part 1. Maximum recommended human dose of part 1 is 10 mg and the maximum dose is 180 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JX2105 | Active Comparator | JX2105 10mg;JX2105 30mg;JX2105 90mg;JX2105 180mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JX2105 | Drug | Oral capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| TEAE/SAE | The number, frequency and incidence of TEAE/SAE; The number, frequency and incidence of drug-related TEAE/SAE; | Day1 to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak concentrations (Cmax) of JX2105 and metabolites detected after administration; Area under the drug concentration-time curve (AUC0-last) from 0h to the last sample collection time t where the concentration of JX2105 and metabolites can be accurately determined; | Day1 to Day 10 |
| AUC0-∞ |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100015 | China |
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Parallel Assignment
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Double-Blind
| Drug |
Oral capsule |
|
Area under the drug concentration-time curve of JX2105 and metabolites from 0 to infinity (AUC0-∞) |
| Day1 to Day 10 |
| Tmax | Peak time of JX2105 and its metabolites | Day1 to Day 10 |
| t1/2z | End phase elimination half-life | Day1 to Day 10 |
| λz | End-phase elimination rate constant | Day1 to Day 10 |
| Vz/F | Apparent volume of distribution | Day1 to Day 10 |
| CLz/F | Apparent clearance | Day1 to Day 10 |
| MRT0-last、 MRT0-∞ | Mean residence time | Day1 to Day 10 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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