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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NovImmune SA
ClinicalTrials.gov Identifier:
NCT01459562
First received: October 17, 2011
Last updated: February 17, 2014
Last verified: January 2013
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: NI-0501
Drug: Placebo
Phase 1

Study Type: Interventional
Official Title: A Randomized Double-blinded Placebo Controlled Single Center Phase I Study of Escalating Single Intravenous Doses of NI-0501 in Healthy Volunteers

Further study details as provided by NovImmune SA:

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

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

Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NI-0501 Drug: NI-0501
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459562

Locations
United Kingdom
HMR
London, United Kingdom
ICON
Manchester, United Kingdom
Sponsors and Collaborators
NovImmune SA
Investigators
Principal Investigator: Steve Warrington, MD HMR
Principal Investigator: Peter Dewland, MD ICON
  More Information

No publications provided

Responsible Party: NovImmune SA
ClinicalTrials.gov Identifier: NCT01459562     History of Changes
Other Study ID Numbers: NI-0501-03
Study First Received: October 17, 2011
Last Updated: February 17, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014