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

Light Chain Bioscience

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: Monoclonal antibody

Study type: Interventional

Funder types: Industry

Identifiers

NCT01808469

NI-0101-01_

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

NI-0101

Experimental group

Description:

NI-0101 is an anti-Toll-like receptor monoclonal antibody.

Treatment:

Biological: Monoclonal antibody

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Biological: Monoclonal antibody