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This is a single-Center, randomized, double-Blind, placebo-controlled, multiple ascending-dose Phase I trail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR4640 2.5mg | Experimental | 6 subjects assigned to 2.5mg SHR4640 and 2 subjects assigned to placebo |
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| SHR4640 10mg | Experimental | 6 subjects assigned to 10mg SHR4640 and 2 subjects assigned to placebo |
|
| SHR4640 20mg | Experimental | 6 subjects assigned to 20mg SHR4640 and 2 subjects assigned to placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR4640 | Drug | SHR4640 or placebo once daily for a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events in terms of changes in Hematology | Hemoglobin Hematocrit Erythrocytes count Mean cell volume, Mean cell hemoglobin concentration, Leukocytes count, Neutrophils count, Lymphocytes count, Monocytes count, Eosinophils count, Basophils count, Platelets count | Up to Day 14 |
| Incidence of Adverse events in terms of changes in Urinalysis | Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites | Up to Day 14 |
| Incidence of Adverse events in terms of changes in Biochemistry (fasting) | Including Serum creatinine, Urea, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyl transferase, Total bilirubin, Total protein, Albumin, Alkaline phosphatase, Serum uric acid, Glucose, Triglycerides, Total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol | Up to Day 14 |
| Incidence of Adverse events in terms of changes in Physical examinations | Review of body weight and height; general appearance; head; eyes; ears/nose/throat; neck; lymph nodes; neurological and musculoskeletal systems; heart; lungs; abdomen; skin; and extremities | Up to Day 14 |
| Incidence of Adverse events in terms of changes in Vital signs | Oral temperature, respiratory rate, blood pressure, and pulse rate | Up to Day 14 |
| Incidence of Adverse events in terms of changes in 12-lead ECGs | The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) (of single dose and at stable status) | Up to Day 10 | |
| Area under the plasma concentration versus time curve (AUC) (of single dose and at stable status) | Up to Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
1) Prescription medication within 2 weeks of Day 1. 2) Over-the-counter medication within 1 week of Day 1. 3) Use of any over the-counter, nutraceuticals, or prescription medications that might interfere with the absorption, distribution, metabolism, or excretion of SHR4640 (proton-pump inhibitor, fluconazole, indomethacin, ranitidine, flurbiprofen, probenecid, aprepitant, etc.) within 1 month of Day 1.
18. Received the last dose of a study drug (or treatment with a medical device) within 30 days or 5 T1/2 (whichever is longer) of the study drug of Day 1 or are currently participating in another study of a study drug (or medical device).
19. Any other medical or psychological condition, which in the opinion of the Investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or to complete the study.
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| Name | Affiliation | Role |
|---|---|---|
| Sam Salman, B.Sc.BMBS | Linear Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atridia Pty Limited | Sydney | New South Wales | 2000 | Australia |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| C000720748 | ruzinurad |
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| Up to Day 14 |
| Half-time (T1/2) (of single dose and at stable status) | Up to Day 10 |
| Time to the peak plasma concentration (Tmax) (of single dose and at stable status) | Up to Day 10 |
| Changes in serum uric acid concentration from baseline | Up to Day 10 |
| Changes in urinary uric acid excretion from baseline | Up to Day 10 |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |