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Safety Study on IdeS in Healthy Volounteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01802697
First Posted: March 1, 2013
Last Update Posted: January 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hansa Medical AB
  Purpose
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).

Condition Intervention Phase
Healthy Drug: IdeS Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Hansa Medical AB:

Primary Outcome Measures:
  • Safety as measured by adverse events [ Time Frame: 64 days ]

Secondary Outcome Measures:
  • Peak plasma concentration of IdeS [ Time Frame: 7 days ]

Other Outcome Measures:
  • Total IgG concentration [ Time Frame: 64 days ]

Enrollment: 29
Study Start Date: February 2013
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IdeS
Intravenous infusion
Drug: IdeS
Placebo Comparator: PBS Buffer
Intravenous infusion
Drug: Placebo

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/kg body weight (BW).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802697


Locations
Sweden
Clinical Trial Unit, FoU centrum Skåne, Skåne University hospital
Lund, Sweden, 22185
Sponsors and Collaborators
Hansa Medical AB
Investigators
Principal Investigator: Ulf Malmqvist, MD, PhD Clinical Trial Unit, SUS, Lund, Sweden
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hansa Medical AB
ClinicalTrials.gov Identifier: NCT01802697     History of Changes
Other Study ID Numbers: 11-HMedIdeS-01
2012-000969-21 ( EudraCT Number )
First Submitted: February 27, 2013
First Posted: March 1, 2013
Last Update Posted: January 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hansa Medical AB:
volunteers