Safety Study on IdeS in Healthy Volounteers

A Phase i Single Center Study to Evalute the Safety, Tolerability and Pharmacokinetics of Intravenous IdeS After Administration of Single Ascending Doses in Healthy Male Subjects

This is a first in man study to assess safety and tolerability of the IgG cleaving enzyme Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS).

A phase I study (11-HMedIdeS-01, EudraCT no. 2012-000 969-21) first in man single ascending dose study in 29 healthy subjects to investigate if IdeS is safe and well tolerated in doses up to 0.24 mg/kg body weight (BW).

Inclusion Criteria:

• Ability to understand and sign informed consent
• BMI 19-30

Exclusion Criteria:

• Clinically significant disease

• Positive HIV, hepatistis B or C

  • Drug abuse

• Smoking

• Use of medication except paracetamol