Safety Study on IdeS in Healthy Volounteers

January 18, 2017 updated by: Hansa Biopharma AB

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 22185
        • Clinical Trial Unit, FoU centrum Skåne, Skåne University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IdeS
Intravenous infusion
Drug: IdeS
Placebo Comparator: PBS Buffer
Intravenous infusion
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety as measured by adverse events
Time Frame: 64 days
64 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak plasma concentration of IdeS
Time Frame: 7 days
7 days

Other Outcome Measures

Outcome Measure
Time Frame
Total IgG concentration
Time Frame: 64 days
64 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hansa Biopharma AB

Investigators

  • Principal Investigator: Ulf Malmqvist, MD, PhD, Clinical Trial Unit, SUS, Lund, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

February 27, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11-HMedIdeS-01
  • 2012-000969-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe