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Safety Study on IdeS in Healthy Volounteers

NCT01802697 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-01-19

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

DRUG

IdeS

DRUG

Placebo

Sponsors & Collaborators

  • Hansa Biopharma AB

    lead INDUSTRY

Principal Investigators

  • Ulf Malmqvist, MD, PhD · Clinical Trial Unit, SUS, Lund, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-12-31
Completion
2014-02-28

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01802697 on ClinicalTrials.gov