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The purpose of this study is to evaluate the safety,tolerability and pharmacokinetics properties of KLA318-2 Nanocrystal Injection after a single intravenous injection in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KLA318-2 Nanocrystal Injection 60mg | Experimental | 12 participants receive KLA318-2 60mg |
|
| KLA318-2 Nanocrystal Injection 120mg | Active Comparator | Period 1, 6 participants receive KLA318-2 120mg → 6 participants receive Celebrex Capsule 200mg; Period 2, 6 participants receive Celebrex Capsule 200mg → 6 participants receive KLA318-2 120mg |
|
| KLA318-2 Nanocrystal Injection 180mg | Active Comparator | Period 1, 6 participants receive KLA318-2 180mg → 6 participants receive Celebrex Capsules 400mg; Period 2, 6 participants receive Celebrex Capsules 400mg → 6 participants receive KLA318-2 180mg |
|
| KLA318-2 Nanocrystal Injection 240mg | Experimental | 12 participants receive KLA318-2 240mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLA318-2 Nanocrystal Injection | Drug | Intravenous injection, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | UP to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter Cmax | Maximum peak plasma concentration (Cmax) after single dose and in a steady state after multiple doses | UP to Day 3 |
| PK parameter Tmax | Time of Cmax (Tmax) after single dose and in a steady state after multiple doses |
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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 |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) | Recruiting | Jinan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Celebrex Capsule | Drug | P.O., single dose |
|
| UP to Day 3 |
| PK parameter AUC0-t | Area under the concentration-time curve (AUC0-t) from time zero to time "t" after single dose and in a steady state after multiple doses | UP to Day 3 |
| PK parameter AUC0-∞ | AUC from time zero to infinity (AUC0-∞) after single dose and in a steady state after multiple doses | UP to Day 3 |
| PK parameter t1/2 | Terminal-phase elimination half-life (t1/2) after single dose and in a steady state after multiple doses | UP to Day 3 |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |