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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Biological: Monoclonal antibody

• Registration Number: NCT01808469
• Lead Sponsor: Light Chain Bioscience - 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NI-0101	Monoclonal antibody	NI-0101 is an anti-Toll-like receptor monoclonal antibody.
Placebo	Monoclonal antibody	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

Locations (1)

Centre for Human Drug Research; 🇳🇱 Leiden, Netherlands