First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers
Sponsor
Light Chain Bioscience - Novimmune SA (Industry)
Overall Status
Completed
CT.gov ID
NCT01459562
Collaborator
(none)
2
2
16
Study Details
Study Description
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 |
|---|---|---|
|
Phase 1 |
Study Design
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
Study Start Date
:
Sep 1, 2011
Actual Primary Completion Date
:
Jan 1, 2013
Actual Study Completion Date
:
Jan 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NI-0501
|
Drug: NI-0501
|
| Placebo Comparator: Placebo
|
Drug: Placebo
|
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HMR | London | United Kingdom | ||
| 2 | ICON | Manchester | United Kingdom |
Sponsors and Collaborators
- Light Chain Bioscience - Novimmune SA
Investigators
- Principal Investigator: Steve Warrington, MD, HMR
- Principal Investigator: Peter Dewland, MD, ICON plc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Light Chain Bioscience - Novimmune SA
ClinicalTrials.gov Identifier:
NCT01459562
Other Study ID Numbers:
- NI-0501-03
First Posted:
Oct 25, 2011
Last Update Posted:
Feb 19, 2014
Last Verified:
Jan 1, 2013