Trial | NCT01802697  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    imlifidase ...

  • Study Participants

    29
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).
Study Started
Feb 28
2013
Primary Completion
Dec 31
2013
Study Completion
Feb 28
2014
Last Update
Jan 19
2017
Estimate

Drug IdeS

Drug Placebo

IdeS Experimental

Intravenous infusion

PBS Buffer Placebo Comparator

Intravenous infusion

Criteria 

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
No Results Posted