Table 4.
Hematological analysis and Serum biochemistry analysis
| Hematology | Reference Range | ||||||
|---|---|---|---|---|---|---|---|
| Placebo | Low Dose | High Dose | |||||
| Visit 1 | Visit 4 | Visit 1 | Visit 4 | Visit 1 | Visit 4 | ||
| WBC (x10E3/uL) | 7.0 ± 1.5 | 6.9 ± 1.5 | 7.1 ± 1.9 | 7.0 ± 2.0 | 6.7 ± 1.9 | 6.5 ± 1.5 | 3.4–10.8 |
| RBC (x10E6/uL) | 4.7 ± 0.4 | 4.6 ± 0.4 | 4.7 ± 0.3 | 4.6 ± 0.3 | 4.6 ± 0.4 | 4.6 ± 0.4 | 3.8–5.8 |
| Hemoglobin (g/dL) | 14.2 ± 4.1 | 13.7 ± 1.1 | 13.6 ± 1.2 | 13.4 ± 1.2 | 13.8 ± 1.5 | 13.8 ± 1.4 | 11.1–17.7 |
| Hematocrit (%) | 39.9 ± 5.8 | 40.8 ± 2.9 | 40.5 ± 3.0 | 40.2 ± 2.8 | 41.3 ± 3.8 | 41.1 ± 3.7 | 34.0–46.6 |
| MCV (fL) | 87.6 ± 4.7 | 88.1 ± 4.3 | 87.0 ± 4.9 | 87.0 ± 4.9 | 89.2 ± 4.9 | 88.8 ± 4.2 | 79.0–97.0 |
| MCH (pg) | 29.4 ± 1.9 | 30.7 ± 8.8 | 29.1 ± 2.1 | 29.1 ± 2.2 | 29.8 ± 2.0 | 29.6 ± 2.3 | 26.6–33.0 |
| MCHC (g/dL) | 33.6 ± 1.0 | 33.5 ± 1.1 | 33.5 ± 1.0 | 33.4 ± 1.1 | 33.4 ± 1.1 | 33.6 ± 0.9 | 31.5–35.7 |
| RDW (%) | 13.9 ± 0.9 | 14.0 ± 0.8 | 14.2 ± 0.9 | 14.3 ± 1.0 | 13.9 ± 0.8 | 14.1 ± 1.4 | 12.3–15.4 |
| Platelets (x10E3/uL) | 270.1 ± 59.4 | 268.6 ± 53.0 | 277.6 ± 79.6 | 277.6 ± 81.1 | 276.6 ± 59.4 | 261.8 ± 59.2 | 150–379 |
| Neutrophils (%) | 58.4 ± 8.3 | 59.5 ± 8.6 | 59.0 ± 9.3 | 59.9 ± 7.3 | 56.4 ± 9.1 | 56.8 ± 8.6 | 40–74 |
| Lymphocytes (%) | 31.6 ± 7.3 | 31.1 ± 7.7 | 31.6 ± 7.2 | 31.2 ± 6.3 | 33.1 ± 8.3 | 33.1 ± 7.9 | 14–46 |
| Monocytes (%) | 7.1 ± 2.0 | 6.6 ± 2.0 | 6.4 ± 1.9 | 6.3 ± 1.7 | 6.9 ± 2.1 | 6.5 ± 2.0 | 4–12 |
| Eosinophils (%) | 2.4 ± 1.3 | 2.3 ± 1.5 | 2.2 ± 2.4 | 2.2 ± 1.7 | 2.9 ± 2.1 | 3.0 ± 1.6 | 0–5 |
| Basophils (%) | 0.3 ± 0.5 | 0.4 ± 0.5 | 0.4 ± 0.5 | 0.5 ± 0.5 | 0.6 ± 0.8 | 0.6 ± 0.5 | 0–3 |
| Neutrophils, abs (x10E3) | 4.1 ± 1.2 | 4.1 ± 1.2 | 4.3 ± 1.5 | 4.2 ± 1.6 | 3.8 ± 1.5 | 3.7 ± 1.1 | 1.4–7.0 |
| Lymphocytes, abs (x10E3) | 2.3 ± 0.7 | 2.1 ± 0.7 | 2.2 ± 0.7 | 2.1 ± 0.6 | 2.2 ± 0.7 | 2.1 ± 0.6 | 0.7–3.1 |
| Monocytes, abs (x10E3) | 0.5 ± 0.1 | 0.5 ± 0.1 | 0.5 ± 0.2 | 0.4 ± 0.1 | 0.4 ± 0.1 | 0.4 ± 0.2 | 0.1–0.9 |
| Eosinophils, abs (x10E3) | 0.2 ± 0.1 | 0.2 ± 0.1 | 0.2 ± 0.2 | 0.2 ± 0.2 | 0.2 ± 0.1 | 0.2 ± 0.1 | 0.0–0.4 |
| Basophils, abs (x10E3) | 0.0 ± 0.0 | 0.0 ± 0.0 | 0.0 ± 0.0 | 0.0 ± 0.0 | 0.0 ± 0.1 | 0.0 ± 0.0 | 0.0–0.2 |
| Immature Grans (%) | 0.0 ± 0.0 | 0.0 ± 0.1 | 0.3 ± 2.0 | 0.0 ± 0.1 | 0.2 ± 0.6 | 0.0 ± 0.0 | 0–1 |
| Immature Grans, abs (x10E3) | 0.0 ± 0.0 | 0.0 ± 0.0 | 0.0 ± 0.1 | 0.0 ± 0.0 | 0.0 ± 0.0 | 0.0 ± 0.0 | 0.0–0.1 |
| Serum Biochemistry | Reference Range | ||||||
|---|---|---|---|---|---|---|---|
| Placebo | Low Dose | High Dose | |||||
| Visit 1 | Visit 4 | Visit 1 | Visit 4 | Visit 1 | Visit 4 | ||
| Glucose, Serum (mg/dL) | 93.5 ± 28.6 | 98.7 ± 35.7 | 92.9 ± 13.8 | 94.5 ± 22.9 | 100.8 ± 33.4 | 103.8 ± 44.9 | 65–139 |
| BUN (mg/dL) | 13.2 ± 3.7 | 13.2 ± 3.3 | 12.9 ± 4.4 | 12.8 ± 3.5 | 16.0 ± 16.3 | 14.0 ± 4.7 | 5–27 |
| Creatinine, Serum (mg/dL) | 0.8 ± 0.2 | 0.8 ± 0.2 | 0.8 ± 0.2 | 0.8 ± 0.2 | 0.8 ± 0.2 | 0.8 ± 0.2 | 0.57–1.27 |
| eGFR If NonAfrican Am (mL/min/1.732) | 100.2 ± 18.3 | 98.8 ± 17.2 | 122.2 ± 143.9 | 100.2 ± 24.1 | 100.0 ± 14.1 | 104.3 ± 16.0 | >59 |
| eGFR If African Am (mL/min/1.732) | 115.7 ± 20.9 | 114.1 ± 19.8 | 117.9 ± 23.1 | 117.1 ± 23.5 | 115.5 ± 16.4 | 120.2 ± 18.5 | >59 |
| BUN/Creatinine Ratio | 17.1 ± 5.1 | 17.3 ± 4.7 | 17.0 ± 4.9 | 17.0 ± 4.7 | 17.5 ± 5.1 | 18.9 ± 5.4 | 9–23 |
| Sodium, Serum (mmol/L) | 139.4 ± 2.2 | 139.0 ± 2.3 | 139.3 ± 2.3 | 138.9 ± 2.0 | 139.1 ± 2.7 | 138.5 ± 2.9 | 134–144 |
| Potassium, Serum (mmol/L) | 4.1 ± 0.4 | 4.1 ± 0.4 | 4.1 ± 0.3 | 4.1 ± 0.4 | 4.2 ± 0.4 | 4.2 ± 0.3 | 3.5–5.2 |
| Chloride, Serum (mmol/L) | 102.1 ± 2.2 | 101.0 ± 2.2 | 102.0 ± 2.0 | 102.3 ± 1.8 | 101.2 ± 2.5 | 101.2 ± 2.7 | 97–108 |
| Carbon Dioxide, Total (mmol/L) | 22.4 ± 1.9 | 23.0 ± 2.1 | 22.0 ± 1.8 | 22.2 ± 2.1 | 22.8 ± 2.8 | 22.5 ± 2.3 | 18–29 |
| Calcium, Serum (mmol/L) | 9.4 ± 0.3 | 9.4 ± 0.4 | 9.4 ± 0.3 | 9.3 ± 0.4 | 9.5 ± 0.4 | 9.4 ± 0.4 | 8.7–10.2 |
| Protein, Total, Serum (g/dL) | 7.0 ± 0.4 | 7.0 ± 0.4 | 7.1 ± 0.4 | 6.9 ± 0.4 | 7.2 ± 0.4 | 7.0 ± 0.5 | 6.0–8.5 |
| Albumin, Serum (g/dL) | 4.5 ± 0.7 | 4.4 ± 0.3 | 4.4 ± 0.2 | 4.3 ± 0.3 | 4.5 ± 0.3 | 4.3 ± 0.3 | 3.2–4.6 |
| Globulin, Total (g/dL) | 2.6 ± 0.4 | 2.6 ± 0.4 | 2.7 ± 0.4 | 2.6 ± 0.3 | 2.7 ± 0.4 | 2.6 ± 0.4 | 1.5–4.5 |
| A/G Ratio | 1.7 ± 0.3 | 2.0 ± 2.0 | 1.7 ± 0.3 | 1.7 ± 0.3 | 1.7 ± 0.4 | 1.7 ± 0.3 | 0.7–2.0 |
| Bilurubin, Total (mg/dL) | 0.4 ± 0.2 | 0.5 ± 0.2 | 0.4 ± 0.2 | 0.4 ± 0.3 | 0.4 ± 0.2 | 0.4 ± 0.2 | 0.0–1.2 |
| Alkaline Phosphatase, S (IU/L) | 78.7 ± 26.3 | 75.7 ± 26.8 | 73.4 ± 17.7 | 69.2 ± 14.2 | 78.5 ± 23.1 | 77.0 ± 24.0 | 39–142 |
| AST (SGOT) (IU/L) | 22.8 ± 10.1 | 22.8 ± 9.8 | 20.0 ± 5.9 | 20.6 ± 8.0 | 23.1 ± 10.1 | 21.8 ± 8.2 | 0–40 |
| ALT (SGPT)(IU/L) | 26.7 ± 20.5 | 26.9 ± 26.3 | 21.9 ± 11.0 | 23.2 ± 15.6 | 23.9 ± 14.5 | 24.6 ± 15.2 | 0–44 |
| Bilirubin, Direct (mg/dL) | 0.1 ± 0.0 | 0.1 ± 0.0 | 0.1 ± 0.0 | 0.1 ± 0.0 | 0.1 ± 0.1 | 0.1 ± 0.0 | 0.0–0.4 |