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

• ClinicalTrials.gov Identifier: NCT01459562
• Recruitment Status: Completed
• First Posted: October 25, 2011
• Last Update Posted: February 19, 2014
• Sponsor: Light Chain Bioscience - Novimmune SA
• Information provided by (Responsible Party): Light Chain Bioscience - Novimmune SA

Tracking Information

• First Submitted Date: October 17, 2011
• First Posted Date: October 25, 2011
• Last Update Posted Date: February 19, 2014
• Study Start Date: September 2011
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 24, 2011): Clinical and laboratory parameters after single escalating intravenous doses of NI-0501 in healthy volunteers
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 24, 2011): Area Under Curve (AUC) Time Frame: predose, 0,1,2,4,8,10,24,48,96 hours post-dose
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers
• Official Title: A Randomized Double-blinded Placebo Controlled Single Center Phase I Study of Escalating Single Intravenous Doses of NI-0501 in Healthy Volunteers
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Not Provided
• Condition: Healthy Volunteers

Intervention

• Drug: NI-0501
• Drug: Placebo

Study Arms

• Experimental: NI-0501
  Intervention: Drug: NI-0501
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01459562
• Other Study ID Numbers: NI-0501-03
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Light Chain Bioscience - Novimmune SA
• Original Responsible Party: Same as current
• Current Study Sponsor: Light Chain Bioscience - Novimmune SA
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Steve Warrington, MD; HMR
• Principal Investigator: Peter Dewland, MD; ICON plc

• PRS Account: Light Chain Bioscience - Novimmune SA
• Verification Date: January 2013