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Completed

NCT Number: NCT01802697

Safety Study on IdeS in Healthy Volounteers

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).

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Unit, FoU centrum Skåne, Skåne University hospital

Lund, 22185, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IdeS

Drug

Placebo

Drug

Primary outcomes

  1. Safety as measured by adverse events

    Time frame: 64 days

Secondary outcomes

  1. Peak plasma concentration of IdeS

    Time frame: 7 days

Other outcomes

  1. Total IgG concentration

    Time frame: 64 days

Sponsors and collaborators

Lead sponsor

Hansa Biopharma AB

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 1, 2013
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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