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Table 1 Groups of RccHan:WIST rats for 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

Group

Dose route

Dose level (mg/kg/dose)

Number of animals

Subgroup 1

Toxicity

Treatment free

Male

Female

Male

Female

1

IV

0 (control)

10

10

5

5

2

IV

15 (low)

10

10

3

IV

50 (intermediate)

10

10

4

IV

150 (high)

10

10

5

5

5

IM

2 mg per dose (low)

10

10

5

5

   

Subgroup 2

Toxicokinetics

  

Male

Female

  

1

IV

0 (control)

3

3

  

2

IV

15 (low)

9

9

  

3

IV

50 (intermediate)

9

9

  

4

IV

150 (high)

9

9

  

5

IM

2 mg per dose (low)

9

9

  
   

Subgroup 3

Hormone

  

Male

Female

  

1

IV

0 (control)

5

5

  

2

IV

15 (low)

5

5

  

3

IV

50 (intermediate)

5

5

  

4

IV

150 (high)

5

5

  

5

IM

2 mg per dose (low)

5

5

  
  1. IV intravenous infusion; IM intramuscular injection