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OpenTrials
Completed

NCT Number: NCT01808469

First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research

Leiden, 2333 CL, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults between 18 and 40 years old (inclusive) having a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), able to adhere to study protocol requirements and having signed informed consent.

Exclusion criteria

  • Any abnormal past or present clinically relevant medical history or any relevant abnormal laboratory parameters at screening that will prevent to consider the volunteers as healthy for the study.

Treatment and study plan

Monoclonal antibody

Biological

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Light Chain Bioscience - Novimmune SA

Industry

Registry information

Official study 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.

Acronym: NI-0101-01

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2013
Registry last updated
Oct 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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