NCT01255501CompletedPhase 1
A First in Man Randomized Placebo Controlled Study of Single Ascending Intravenous Doses of NI-0701 in Healthy Volunteers
Light Chain Bioscience - Novimmune SA0 sitesStarted: December 7, 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Primary Endpoint
- Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
NI-0701
Experimental
Intervention: NI-0701 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers
Secondary Outcomes
- 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
Investigators
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