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Table 3 Adverse events in healthy volunteers (n = 48).

From: Safety and tolerability of the antimicrobial peptide human lactoferrin 1-11 (hLF1-11)

 

Placebo, n (%)

hLF1-11, 0.005 mg, n (%)

hLF1-11, 0.05 mg, n (%)

hLF1-11, 0.5 mg, n (%)

hLF1-11, 5 mg, n (%)

Study 1 (single dosing):

     

Subjects per group

8 (100)

6 (100)

6 (100)

6 (100)

6 (100)

Diarrhoea

-

1 (16.7)

-

-

-

Dizziness

-

-

-

-

1 (16.7)

Epistaxis

1 (12.5)

-

-

-

-

Feeling cold

-

1 (16.7)

-

-

-

Flatulence

-

-

-

-

1 (16.7)

Headache

1 (12.5)

1 (16.7)

-

-

1 (16.7)

Increased appetite

1 (12.5)

-

-

-

-

Phlebitis

-

-

-

-

1 (16.7)

Purpura

-

-

-

-

1 (16.7)

Somnolence

1 (12.5)

-

-

-

1 (16.7)

Study 2 (multiple dosing):

     

Subjects per group

3a (100)

  

6 (100)

7a (100)

ALT increase

-

  

2 (33.3)

3 (42.9)

AST increase

-

  

-

1 (14.3)

Dry skin

1 (33.3)

  

1 (16.7)

-

Hyperhydrosis

-

  

1 (16.7)

-

Injection site erythaema

1 (33.3)

  

-

-

Injection site pain

1 (33.3)

  

-

-

Injection site reaction

-

  

2 (33.3)

1 (14.3)

Malaise

-

  

1 (16.7)

-

Nausea

-

  

1 (16.7)

-

  1. All listed events were rated blindly as possibly related to treatment.
  2. aOne subject in the placebo group (no. 016) received one dose of hLF1-11 5 mg (day 4) due to administrative error, therefore events were computed in the 5 mg group.
  3. ALT = alanine aminotransferase; AST = aspartate aminotransferase.