NCT01802697

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

February 27, 2013

Last Update Submit

January 18, 2017

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

  • Safety as measured by adverse events

    64 days

Secondary Outcomes (1)

  • Peak plasma concentration of IdeS

    7 days

Other Outcomes (1)

  • Total IgG concentration

    64 days

Study Arms (2)

IdeS

EXPERIMENTAL

Intravenous infusion

Drug: IdeS

PBS Buffer

PLACEBO COMPARATOR

Intravenous infusion

Drug: Placebo

Interventions

IdeSDRUG
IdeS
PlaceboDRUG
PBS Buffer

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to understand and sign informed consent
  • BMI 19-30

You may not qualify if:

  • Clinically significant disease
  • Positive HIV, hepatistis B or C
  • Drug abuse
  • Smoking
  • Use of medication except paracetamol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Unit, FoU centrum Skåne, Skåne University hospital

Lund, 22185, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 26177518DERIVED

Study Officials

  • Ulf Malmqvist, MD, PhD

    Clinical Trial Unit, SUS, Lund, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2013

First Posted

March 1, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

January 19, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)