This is a single-Center, randomized, double-Blind, placebo-controlled, multiple ascending-dose Phase I trail.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
24
SHR4640 or placebo once daily for a week
Atridia Pty Limited
Sydney, New South Wales, Australia
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to Day 14
Incidence of Adverse events in terms of changes in Vital signs
Oral temperature, respiratory rate, blood pressure, and pulse rate
Time frame: 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.
Time frame: Up to Day 14
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Peak Plasma Concentration (Cmax) (of single dose and at stable status)
Time frame: Up to Day 10
Area under the plasma concentration versus time curve (AUC) (of single dose and at stable status)
Time frame: Up to Day 10
Half-time (T1/2) (of single dose and at stable status)
Time frame: Up to Day 10
Time to the peak plasma concentration (Tmax) (of single dose and at stable status)
Time frame: Up to Day 10
Changes in serum uric acid concentration from baseline
Time frame: Up to Day 10
Changes in urinary uric acid excretion from baseline
Time frame: Up to Day 10