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NCT01802697 Clinical Trial

Safety Study on IdeS in Healthy Volounteers

Healthy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01802697
Other study ID # 11-HMedIdeS-01
Secondary ID 2012-000969-21
Status Completed
Phase Phase 1
First received February 27, 2013
Last updated January 18, 2017
Start date February 2013
Est. completion date February 2014

Study information
Verified date January 2017
Source Hansa Medical AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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/kg body weight (BW).

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date February 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IdeS

• Placebo

Locations
Country Name City State
Sweden Clinical Trial Unit, FoU centrum Skåne, Skåne University hospital Lund

Sponsors (1)
Lead Sponsor Collaborator
Hansa Medical AB

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Other Total IgG concentration 64 days
Primary Safety as measured by adverse events 64 days
Secondary Peak plasma concentration of IdeS 7 days
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