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A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI128 | Experimental | IBI128 po. QD(Quaque Die) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dose-5 group | Drug | IBI128 300mg po. QD(Quaque Die) |
| |
| dose-1 group |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Cmax | Maximum plasma concentration(Cmax) of IBI128 | Up to Day 8 |
| PK parameter: AUC | Area under the concentration-time curve (AUC)of IBI128 | Up to Day 8 |
| PK parameter: Tmax | Time to ahieve Cmax | Up to Day 8 |
| PK parameter: T1/2 | The time that takes for the dlimination processes to reduce the plasma concentration of the drug in the body by 50%. | Up to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameter: AE | Number of subjects with Adverse Event | Up to Day 8 |
| PD parameter: serum UA (uric acid) | The Percentage change of serum UA assesed by Area Under Curve 24,Cmean,24,Cmean,24 of IBI128 from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated | Zhengzhou | Henan | 450000 | China |
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| ID | Term |
|---|---|
| D015210 | Arthritis, Gouty |
| ID | Term |
|---|---|
| D006073 | Gout |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Drug |
IBI128 25mg po. QD(Quaque Die) |
|
| dose-2 group | Drug | IBI128 50mg po. QD(Quaque Die) |
|
| dose-4 group | Drug | IBI128 200mg po. QD(Quaque Die) |
|
| dose-3 group | Drug | IBI128 100mg po. QD(Quaque Die) |
|
| Up to Day 8 |
| Tolerability parameter: SAE | Number of subjects with Serious Adverse Event | Up to Day 8 |
| D000070657 |
| Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |