Table 6.
Blood Chemistry of Beagle Dogs Following 27 Days of Topical Ophthalmic Administration of QLS-101
| Males | |||||
|---|---|---|---|---|---|
| Vehicle | QLS-101 (0.8 mg/eye/dose) | QLS-101 (1.6 mg/dose/eye) | QLS-101 (3.2 mg/eye/dose) | Historical control range | |
| Aspartate aminotransferase (U/L) | 25.2 ± 5.8 | 26.0 ± 2.6 | 26.7 ± 3.5 | 28.4 ± 5.6 | 22.0–46.4 |
| Alanine aminotransferase (U/L) | 28.0 ± 5.3 | 28.0 ± 1.7 | 27.3 ± 4.6 | 28.2 ± 5.1 | 21.0–91.7 |
| Alkaline phosphatase (U/L) | 98.0 ± 27.8 | 107.0 ± 48.2 | 89.0 ± 9.2 | 81.2 ± 16.0 | 46.6–531.7 |
| Total bilirubin (mg/dL) | 0.028 ± 0.018 | 0.013 ± 0.023 | 0.013 ± 0.023 | 0.044 ± 0.026 | 0.000–0.100 |
| Urea nitrogen (mg/dL) | 16.0 ± 1.6 | 13.7 ± 2.3 | 15.7 ± 2.9 | 17.4 ± 4.9 | 10.0–24.0 |
| Creatinine (mg/dL) | 0.60 ± 0.00 | 0.60 ± 0.00 | 0.57 ± 0.06 | 0.58 ± 0.08 | 0.30–0.90 |
| Creatinine kinase (U/L) | 197.0 ± 50.6 | 224.7 ± 44.7 | 179.0 ± 22.3 | 188.4 ± 76.7 | 138.8–634.9 |
| Glucose (mg/dL) | 99.2 ± 3.3 | 105.3 ± 3.2 | 98.0 ± 7.8 | 101.2 ± 3.6 | 82.2–117.0 |
| Cholesterol (mg/dL) | 146.6 ± 16.8 | 137.3 ± 13.4 | 158.0 ± 9.8 | 120.6 ± 14.4 | 110.0–201.7 |
| Triglycerides (mg/dL) | 34.4 ± 6.3 | 35.0 ± 5.2 | 34.7 ± 6.4 | 27.2 ± 6.8 | 18.0–104.0 |
| Total protein (g/dL) | 5.12 ± 0.19 | 5.13 ± 0.23 | 4.77 ± 0.12 | 4.88 ± 0.18 | 5.00–6.60 |
| Albumin/globulin ratio (G) | 1.68 ± 0.11 | 1.80 ± 0.10 | 1.97 ± 0.12 | 1.70 ± 0.17 | 1.20–2.34 |
| Calcium (mg/dL) | 10.24 ± 0.26 | 10.37 ± 0.15 | 10.17 ± 0.25 | 9.98 ± 0.25 | 9.70–10.97 |
| Phosphorus (mg/dL) | 5.60 ± 0.69 | 5.60 ± 0.61 | 5.43 ± 0.15 | 5.20 ± 0.34 | 4.26–6.80 |
| Sodium (mmol/L) | 146.2 ± 1.1 | 145.0 ± 1.0 | 145.3 ± 1.2 | 144.8 ± 0.4 | 142.6–149.0 |
| Potassium (mmol/L) | 4.56 ± 0.30 | 4.43 ± 0.06 | 4.50 ± 0.26 | 4.48 ± 0.19 | 4.10–5.20 |
| Chloride (mmol/L) | 110.4 ± 1.8 | 108.3 ± 1.5 | 110.0 ± 0.0 | 110.2 ± 0.8 | 103.0–114.0 |
| Females | |||||
|---|---|---|---|---|---|
| Vehicle | QLS-101 (0.8 mg/eye/dose) | QLS-101 (1.6 mg/dose/eye) | QLS-101 (3.2 mg/eye/dose) | Historical control range | |
| Aspartate aminotransferase (U/L) |
25.4 ± 1.1 |
34.7 ± 10.7 |
30.0 ± 7.0 |
30.4 ± 6.8 |
22.0–45.0 |
| Alanine aminotransferase (U/L) |
25.6 ± 7.2 |
40.7 ± 20.2 |
26.3 ± 2.5 |
34.0 ± 6.8 |
18.0–42.0 |
| Alkaline phosphatase (U/L) |
89.2 ± 24.9 |
78.3 ± 4.5 |
72.7 ± 11.7 |
93.8 ± 23.3 |
52.0–155.0 |
| Total bilirubin (mg/dL) |
0.048 ± 0.008 |
0.033 ± 0.006 |
0.067 ± 0.012 |
0.048 ± 0.008 |
0.000–0.110 |
| Urea nitrogen (mg/dL) |
16.2 ± 2.8 |
15.0 ± 1.0 |
14.3 ± 1.5 |
14.4 ± 2.3 |
11.0–22.0 |
| Creatinine (mg/dL) |
0.60 ± 0.00 |
0.53 ± 0.06 |
0.60 ± 0.00 |
0.54 ± 0.05 |
0.50–0.80 |
| Creatinine kinase (U/L) |
217.2 ± 52.6 |
407.0 ± 283.7 |
216.0 ± 87.5 |
318.4 ± 207.4 |
135.6–402.2 |
| Glucose (mg/dL) |
97.4 ± 5.1 |
98.0 ± 6.6 |
94.7 ± 5.0 |
93.0 ± 4.5 |
77.0–112.0 |
| Cholesterol (mg/dL) |
146.0 ± 13.2 |
126.0 ± 9.2 |
128.7 ± 6.8 |
115.2 ± 24.8 |
110.0–204.0 |
| Triglycerides (mg/dL) |
37.0 ± 7.1 |
24.0 ± 3.6 |
35.3 ± 5.5 |
24.2 ± 4.8 |
19.0–55.0 |
| Total protein (g/dL) |
5.16 ± 0.17 |
3.30 ± 0.10 |
3.53 ± 0.12 |
3.48 ± 0.08 |
4.90–6.10 |
| Albumin/globulin ratio (G) |
2.28 ± 0.15 |
1.97 ± 0.12 |
2.17 ± 0.38 |
2.24 ± 0.09 |
1.40–2.60 |
| Calcium (mg/dL) |
10.64 ± 0.17 |
10.37 ± 0.12 |
10.50 ± 0.20 |
10.50 ± 0.17 |
9.70–11.00 |
| Phosphorus (mg/dL) |
5.48 ± 0.33 |
5.03 ± 0.35 |
5.43 ± 0.29 |
5.28 ± 0.33 |
4.30–6.00 |
| Sodium (mmol/L) |
147.0 ± 0.7 |
145.3 ± 0.6 |
146.0 ± 1.0 |
145.4 ± 1.7 |
141.0–149.0 |
| Potassium (mmol/L) |
4.58 ± 0.13 |
4.43 ± 0.23 |
4.67 ± 0.23 |
4.54 ± 0.11 |
4.00–4.90 |
| Chloride (mmol/L) | 109.0 ± 0.7 | 109.7 ± 0.6 | 109.0 ± 1.7 | 109.8 ± 1.1 | 106.0–113.0 |