Safety Study on IdeS in Healthy Volounteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: IdeS; Drug: Placebo

• Registration Number: NCT01802697
• Lead Sponsor: Hansa Biopharma 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).

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-01
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IdeS	IdeS	Intravenous infusion
PBS Buffer	Placebo	Intravenous infusion

Primary Outcome Measures

Name	Time	Method
Safety as measured by adverse events	64 days

Secondary Outcome Measures

Name	Time	Method
Peak plasma concentration of IdeS	7 days

Trial Locations

Locations (1)

Clinical Trial Unit, FoU centrum Skåne, Skåne University hospital; 🇸🇪 Lund, Sweden