Status:
COMPLETED
Safety Study on IdeS in Healthy Volounteers
Lead Sponsor:
Hansa Biopharma AB
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
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).
Detailed Description
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/k...
Eligibility Criteria
Inclusion
- Ability to understand and sign informed consent
- BMI 19-30
Exclusion
- Clinically significant disease
- Positive HIV, hepatistis B or C
- Drug abuse
- Smoking
- Use of medication except paracetamol
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01802697
Start Date
February 1 2013
End Date
February 1 2014
Last Update
January 19 2017
Active Locations (1)
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1
Clinical Trial Unit, FoU centrum Skåne, Skåne University hospital
Lund, Sweden, 22185