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

Table 4 Thyroid hormone levels in the study rats on day 30 post IV and IM administration of different doses of K1-70™

K1-70™ dose	Sex	TSH (μIU/mL)	T3 (nmol/L)	T4 (nmol/L)
K1-70™ dose	Sex	Mean ± SD	Mean ± SD	Mean ± SD
Control	M	0.39 ± 0.28	< 0.50^a	55 ± 7.9
Control	F	0.18 ± 0.16	0.58 ± 0.09	< 33^a
15 mg/kg/dose (IV)	M	40.36 ± 7.78	< 0.46^a	< 26^a
15 mg/kg/dose (IV)	F	35.21 ± 5.38	< 0.46^a	< 26^a
50 mg/kg/dose (IV)	M	39.06 ± 6.65	< 0.46^a	< 26^a
50 mg/kg/dose (IV)	F	39.62 ± 5.91	< 0.46^a	< 26^a
150 mg/kg/dose (IV)	M	36.41 ± 8.83	< 0.46^a	< 26^a
150 mg/kg/dose (IV)	F	33.23 ± 10.91	< 0.46^a	< 26^a
2 mg/dose (IM)	M	37.41 ± 14.42	< 0.46^a	< 30^a
2 mg/dose (IM)	F	31.78 ± 13.32	< 0.46^a	< 26^a

Mean is of n = 10 animals per group per sex. One out of 10 rats injected IM with 2 mg doses of K1-70™ showed normal control levels of TSH 0.43 μIU/mL but T3 and T4 levels below the limit of detection and was not included in the TSH range value. Total T3 levels in the serum were measured using the Siemens Centaur immunoassay system, and Total T4 and TSH levels were measured using Siemens Immulite system
M male, F female
^aThe concentration is below the detection limit

ISSN: 2038-3274