Safety Study on IdeS in Healthy Volounteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01802697

Enrollment

Registered

2013-03-01

Start date

2013-02-28

Completion date

2014-02-28

Last updated

2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

volunteers

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).

Interventions

DRUGIdeS

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety as measured by adverse events	64 days

Secondary

Measure	Time frame
Peak plasma concentration of IdeS	7 days

Other

Measure	Time frame
Total IgG concentration	64 days

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026