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: August 26, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Number of adverse events [ Time Frame: 64 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak plasma concentration of IdeS [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Total IgG concentration [ Time Frame: 64 days ] [ Designated as safety issue: No ]

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
Other Name: IdeS
Placebo Comparator: PBS Buffer
Intravenous infusion
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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

No publications provided

Responsible Party: Hansa Medical AB
ClinicalTrials.gov Identifier: NCT01802697     History of Changes
Other Study ID Numbers: 11-HMedIdeS-01, 2012-000969-21
Study First Received: February 27, 2013
Last Updated: August 26, 2014
Health Authority: Sweden: Swedish medicines product agency

Keywords provided by Hansa Medical AB:
volunteers

ClinicalTrials.gov processed this record on September 22, 2014