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

Light Chain Bioscience - Novimmune SA80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

Monoclonal antibodyBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Centre for Human Drug Research

Leiden, Netherlands

Outcomes

Primary Outcomes

Safety and tolerability of NI-0101 in healthy male/female subjects

* 12 lead ECG * Vital signs * Physical examination * Adverse events * Routine laboratory assessments during 8 weeks post administration.

Time frame: Up to 8 weeks

Secondary Outcomes

Pharmacokinetic parameters of NI-0101

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).

Time frame: Up to 8 weeks

Pharmacodynamic parameters of NI-0101

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.

Time frame: Up to 8 weeks

Data from ClinicalTrials.gov

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