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The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single doses of KLA478 in healthy volunteers;
This study is a single-center, randomized/non-randomized, single ascending dose(SAD), Phase I clinical trial conducted in healthy subjects, divided into two parts:
Part 1 is an open-label single-dose study of active comparator to evaluate the pharmacokinetic characteristics of active comparator in healthy subjects; Part 2 is a randomized, double-blind, placebo-controlled single ascending dose study of KLA478: The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single doses of KLA478 in healthy volunteers;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pramipexole hydrochloride sustained-release tablets 0.375mg | Active Comparator | 10 volunteers receive pramipexole hydrochloride sustained-release tablets 0.375mg |
|
| KLA478 2mg | Experimental | 8 volunteers receive KLA478 2mg,2 volunteers receive the same volume placebo |
|
| KLA478 5mg | Experimental | 8 volunteers receive KLA478 5mg,2 volunteers receive the same volume placebo |
|
| KLA478 10mg | Experimental | 8 volunteers receive KLA478 10mg,2 volunteers receive the same volume placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pramipexole hydrochloride sustained-release tablets | Drug | P.O., single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | Up to Day 109 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter Tmax | Time of Cmax (Tmax) after single dose | up to Day 90 |
| PK parameter Cmax | Maximum peak plasma concentration (Cmax) after single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Qi | Contact | 028-82339360 | qiw@kelun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 201107 | China |
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| KLA478 | Drug | intramuscular injection, single dose |
|
| placebo | Drug | intramuscular injection, single dose |
|
| up to Day 90 |
| PK parameter AUC0-t | Area under the concentration-time curve (AUC0-t) from time zero to time "t" after single dose | up to Day 90 |
| PK parameter AUC0-∞ | AUC from time zero to infinity (AUC0-∞) after single dose | up to Day 90 |
| PK parameter AUC_%Extrap | Area Under the Curve Percent Extrapolated | up to Day 90 |
| PK parameter Tlast | Time of Last measurable concentration | Area Under the Curve Percent Extrapolated |
| PK parameter λz | Elimination Rate Constant | up to Day 90 |
| PK parameter t1/2 | Terminal-phase elimination half-life (t1/2) after single dose | up to Day 90 |
| PK parameter CL/F | Clearance adjusted for bioavailability | up to Day 90 |
| PK parameter Vz/F | Volume of Distribution adjusted for bioavailability | up to Day 90 |
| PK parameter MRT | Mean Resident Time | up to Day 90 |