Trials / Completed
CompletedNCT01808469
First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers
A Randomized, Double Blind, Placebo-controlled, Pharmacokinetics/Pharmacodynamics-guided, Phase I Study in Healthy Volunteers Given Escalating, Single Intravenous Doses of NI-0101 in the Absence and Then in the Presence of a Systemic Lipopolysaccharide Challenge.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Light Chain Bioscience - Novimmune SA · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine the safety, tolerability and distribution and elimination of a novel therapeutic drug when administered to Healthy Volunteers. In addition its effects on some inflammatory parameters will be measured in presence or absence of lipopolysaccharide stimulation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Monoclonal antibody |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2014-03-01
- Completion
- 2014-03-01
- First posted
- 2013-03-11
- Last updated
- 2014-10-24
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01808469. Inclusion in this directory is not an endorsement.