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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 30, 2014