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Safety Study on IdeS in Healthy Volounteers

NCT ID: NCT01802697

Last Updated: 2017-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

Brief Summary

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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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Detailed Description

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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).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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IdeS

Intravenous infusion

Group Type EXPERIMENTAL

IdeS

Intervention Type DRUG

PBS Buffer

Intravenous infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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IdeS

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hansa Biopharma AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulf Malmqvist, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Trial Unit, SUS, Lund, Sweden

Locations

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Clinical Trial Unit, FoU centrum Skåne, Skåne University hospital

Lund, , Sweden

Site Status

Countries

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Sweden

References

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Winstedt L, Jarnum S, Nordahl EA, Olsson A, Runstrom A, Bockermann R, Karlsson C, Malmstrom J, Palmgren GS, Malmqvist U, Bjorck L, Kjellman C. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. eCollection 2015.

Reference Type DERIVED
PMID: 26177518 (View on PubMed)

Other Identifiers

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2012-000969-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11-HMedIdeS-01

Identifier Type: -

Identifier Source: org_study_id

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