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

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

The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.

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