Preclinical studies on the toxicology, pharmacokinetics and safety of K1-70TM a human monoclonal autoantibody to the TSH receptor with TSH antagonist activity

Table 7 Thyroid hormone levels in male and female monkeys post IV administration of different doses of K1-70™

Day	K1-70™ dose (mg/kg/dose)	Sex	TSH (µlU/mL)	T3 (nmol/L)	T4 (nmol/L)
Day	K1-70™ dose (mg/kg/dose)	Sex	Mean ± SD	Mean ± SD	Mean ± SD
Predose	0	M	1.16 ± 0.46	2.35 ± 0.27	45.0 ± 4.6
	0	F	1.29 ± 0.54	2.43 ± 0.25	52.5 ± 15.8
	10	M	0.77 ± 0.57	2.04 ± 0.33	47.3 ± 7.6
	10	F	0.90 ± 0.38	2.91 ± 0.09	54.9 ± 2.6
	30	M	1.18 ± 0.94	2.75 ± 0.69	59.7 ± 2.7
	30	F	0.71 ± 0.11	2.65 ± 0.29	68.4 ± 9.4
	100	M	0.75 ± 0.39	2.31 ± 0.23	50.7 ± 6.6
	100	F	1.42 ± 0.61	2.93 ± 0.44	48.4 ± 10.8
Day 7	0	M	1.09 ± 0.42	1.75 ± 0.13	52.9 ± 6.9
	0	F	1.75 ± 0.55	2.15 ± 0.21	61.4 ± 11.4
	10	M	17.06 ± 4.23	0.83 ± 0.31	26.1 ± 8.4
	10	F	19.47 ± 11.69	0.62 ± 0.12	19.4 ± 1.3
	30	M	27.42 ± 6.78	0.67 ± 0.09	21.0 ± 3.9
	30	F	13.89 ± 2.96	1.01 ± 0.55	26.5 ± 8.8
	100	M	17.17 ± 7.00	0.87 ± 0.39	26.6 ± 8.9
	100	F	12.56 ± 7.65	1.18 ± 0.54	33.4 ± 15.3
Day 22	0	M	1.03 ± 0.35	1.96 ± 0.15	52.3 ± 7.2
	0	F	1.12 ± 0.27	2.19 ± 0.21	51.6 ± 5.8
	10	M	88.05 ± 24.46	1.03 ± 0.49	28.8 ± 12.3
	10	F	114.57 ± 2.47	0.79 ± 0.09	19.9 ± 2.0
	30	M	113.61 ± 4.13	0.63 ± 0.18	19.9 ± 2.1
	30	F	77.80 ± 66.16	1.43 ± 1.11	31.3 ± 17.8
	100	M	86.44 ± 17.03	0.93 ± 0.48	25.8 ± 11.6
	100	F	69.53 ± 48.45	1.64 ± 1.03	32.4 ± 15.0

For 10 mg/kg/dose and 30 mg/kg/dose, mean is of n = 3 animals per group per sex
For control (0 mg/kg/dose) and 100 mg/kg/dose, mean is of n = 5 animals per group per sex
Levels of thyroid hormones in serum, TSH, Total T3 and Total T4 were measured using Siemens Centaur immunoassay system
M male, F female, T3 triiodothyronine, T4 thyroxine, TSH thyroid stimulating hormone

ISSN: 2038-3274