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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01808469

Acronym

NI-0101-01

Enrollment

Registered

2013-03-11

Start date

2012-11-30

Completion date

2014-03-31

Last updated

2014-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

BIOLOGICALMonoclonal antibody

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of NI-0101 in healthy male/female subjects	Up to 8 weeks	* 12 lead ECG * Vital signs * Physical examination * Adverse events * Routine laboratory assessments during 8 weeks post administration.

Secondary

Measure	Time frame	Description
Pharmacokinetic parameters of NI-0101	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	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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026