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Table 3 Thyroid hormone levels in the study rats on day 7 post IV and IM administration of different doses of K1-70™

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

K1-70™ dose

Sex

TSH (μIU/mL)

T3 (nmol/L)

T4 (nmol/L)

Mean ± SD

Mean ± SD

Mean ± SD

Control

M

0.60 ± 0.36

0.74 ± 0.12

78 ± 15.2

F

0.49 ± 0.16

0.75 ± 0.20

56 ± 14.5

15 mg/kg/dose (IV)

M

15.62 ± 3.37

< 0.46a

< 26a

F

18.30 ± 4.86

< 0.46a

< 26a

50 mg/kg/dose (IV)

M

16.82 ± 3.70

< 0.46a

< 26a

F

18.24 ± 3.19

< 0.46a

< 26a

150 mg/kg/dose (IV)

M

15.32 ± 2.23

< 0.46a

< 26a

F

16.20 ± 2.95

< 0.46a

< 26a

2 mg/dose (IM)

M

17.46 ± 4.93

< 0.46a

< 26a

F

13.90 ± 3.08

< 0.46a

< 26a

  1. Mean is of n = 5 animals per group per sex. One out of 10 rats injected IM with 2 mg doses of K1-70™ showed normal control levels of thyroid hormones 0.22 μIU/mL, 0.46 nmol/L and 61 nmol/L for TSH, T3 and T4 respectively and was not included in the range values. 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
  2. M male, F female
  3. aThe concentration is below the detection limit