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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01459562
Recruitment Status : Completed
First Posted : October 25, 2011
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Light Chain Bioscience - Novimmune SA

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: NI-0501 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Official Title: A Randomized Double-blinded Placebo Controlled Single Center Phase I Study of Escalating Single Intravenous Doses of NI-0501 in Healthy Volunteers
Study Start Date : September 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: NI-0501 Drug: NI-0501
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Clinical and laboratory parameters after single escalating intravenous doses of NI-0501 in healthy volunteers

Secondary Outcome Measures :
  1. Area Under Curve (AUC) Time Frame: predose, 0,1,2,4,8,10,24,48,96 hours post-dose

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • any abnormal clinical safety laboratory parameters
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459562


Locations
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United Kingdom
HMR
London, United Kingdom
ICON
Manchester, United Kingdom
Sponsors and Collaborators
Light Chain Bioscience - Novimmune SA
Investigators
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Principal Investigator: Steve Warrington, MD HMR
Principal Investigator: Peter Dewland, MD ICON plc
More Information
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Responsible Party: Light Chain Bioscience - Novimmune SA
ClinicalTrials.gov Identifier: NCT01459562    
Other Study ID Numbers: NI-0501-03
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: January 2013