First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers (NI-0101-01)
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|ClinicalTrials.gov Identifier: NCT01808469|
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : October 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Biological: Monoclonal antibody||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
NI-0101 is an anti-Toll-like receptor monoclonal antibody.
Biological: Monoclonal antibody
Placebo Comparator: Placebo
The placebo to be used for the proposed clinical trial is a sterile solution for intravenous infusion. The placebo is identical to the NI-0101 drug product but does not include the active substance.
Biological: Monoclonal antibody
- Safety and tolerability of NI-0101 in healthy male/female subjects [ Time Frame: Up to 8 weeks ]
- 12 lead ECG
- Vital signs
- Physical examination
- Adverse events
- Routine laboratory assessments
during 8 weeks post administration.
- Pharmacokinetic parameters of NI-0101 [ Time Frame: Up to 8 weeks ]
Blood samples for plasma NI-0101 concentrations.
The following pharmacokinetic parameters of NI-0101 will be measured:
Area under the curve from the time of dosing extrapolated to infinity (AUCinf); Area under curve from the time of dosing to the last measurable concentration (AUClast); AUCinf - AUClast expressed in % of AUCinf (% AUCextr); Systemic drug clearance (CL); Mean residence time (MRT) extrapolated to infinity (MRTinf); Mean residence time (MRT) at last measurable concentration (MRTlast).
- Pharmacodynamic parameters of NI-0101 [ Time Frame: Up to 8 weeks ]
Blood samples for inflammatory markers measured in blood with or without the presence of an exogenous stimulus (lipopolysaccharide).
Cytokine levels induced by ex vivo lipopolysaccharide challenge and circulating cytokine levels induced by in vivo lipopolysaccharide challenge will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808469
|Centre for Human Drug Research|
|Leiden, Netherlands, 2333 CL|
|Principal Investigator:||J. Koos Prof. Burggraaf, MD, Ph||Centre for Human Drug Research, Leiden, The Netherlands|