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First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers (NI-0101-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01808469
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : October 24, 2014
Information provided by (Responsible Party):
NovImmune SA

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: Monoclonal antibody Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NI-0101
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

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01808469

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Centre for Human Drug Research
Leiden, Netherlands, 2333 CL
Sponsors and Collaborators
NovImmune SA
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Principal Investigator: J. Koos Prof. Burggraaf, MD, Ph Centre for Human Drug Research, Leiden, The Netherlands

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Responsible Party: NovImmune SA Identifier: NCT01808469    
Other Study ID Numbers: NI-0101-01_
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs