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Safety Study on IdeS in Healthy Volounteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hansa Medical AB
ClinicalTrials.gov Identifier:
NCT01802697
First received: February 27, 2013
Last updated: January 18, 2017
Last verified: January 2017
  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: Double Blind (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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: February 27, 2013
Last Updated: January 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Hansa Medical AB:
volunteers

ClinicalTrials.gov processed this record on May 25, 2017