Safety Study on IdeS in Healthy Volounteers

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. Identifier: NCT01802697
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : January 19, 2017
Information provided by (Responsible Party):
Hansa Medical AB

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).

Condition or disease Intervention/treatment Phase
Healthy Drug: IdeS Drug: Placebo Phase 1

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
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
Study Start Date : February 2013
Primary Completion Date : December 2013
Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: IdeS
Intravenous infusion
Drug: IdeS
Placebo Comparator: PBS Buffer
Intravenous infusion
Drug: Placebo

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01802697

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hansa Medical AB Identifier: NCT01802697     History of Changes
Other Study ID Numbers: 11-HMedIdeS-01
2012-000969-21 ( EudraCT Number )
First Posted: March 1, 2013    Key Record Dates
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: