Status:

COMPLETED

First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers

Lead Sponsor:

Swedish Orphan Biovitrum

Conditions:

Healthy Volunteers

Eligibility:

All Genders

18-50 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.

Eligibility Criteria

Inclusion

  • healthy adults between 18 and 50 years old
  • non smokers
  • able to adhere to study protocol requirements

Exclusion

  • any abnormal clinical safety laboratory parameters

Key Trial Info

Start Date :

September 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2013

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT01459562

Start Date

September 1 2011

End Date

January 1 2013

Last Update

August 9 2023

Active Locations (2)

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Page 1 of 1 (2 locations)

1

HMR

London, United Kingdom

2

ICON

Manchester, United Kingdom