First in Human Study of NI-0701 in Healthy Volunteers
- Registration Number
- NCT01255501
- Lead Sponsor
- Light Chain Bioscience - Novimmune SA
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
- Non smokers
- Able to adhere to study visits and protocol requirements
Exclusion Criteria
- Any clinical safety laboratory measurements value > Grade 1 on WHO Toxicity Scale
- Established or recurrent history of allergic reactions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Placebo Placebo - NI-0701 NI-0701 -
- Primary Outcome Measures
Name Time Method Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers
- Secondary Outcome Measures
Name Time Method NI-0701 Pharmacokinetic parameters in healthy volunteers NI-0701 plasma pharmacodynamic effects upon NI-0701 single intravenous infusion Pharmacodynamic effects of NI-0701 on Histamine skin-induced wheal and flare Immunogenicity of NI-0701