A randomized, double-blind, placebo-controlled PK/PD guided, phase I study in healthy volunteers given escalating, single intravenous doses of NI-0101 in the absence or presence of a systemic LPS challenge.

A randomized, double-blind, placebo-controlled PK/PD guided, phase I study in healthy volunteers given escalating, single intravenous doses of NI-0101 in the absence or presence of a systemic LPS challenge. - Phase 1 NI-0101-01.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37163

Enrollment

100

Registered

2012-09-25

Start date

2012-11-20

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Rheumatoid arthritis.

Interventions

A single intravenous infusion of NI-0101 or placebo without (Part 1) or with (Part 2) an in vivo LPS challenge. NI-0101 is a humanized immunoglobulin gamma (IgG1) kappa monoclonal antibody (mAb) th

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and female volunteers; Signed the informed consent prior to any study related procedure; aged between 18 and 40 years (inclusive); BMI between 18 and 30 kg/m2 (inclusive); known genotype for the Fc*RIIa receptor;

Exclusion criteria

Exclusion criteria: Clinically significant abnormalities; pregncy or breast feeding; susceptibility for infections and/or immunocompromised state and/or latent TB; sepsis in history;

Design outcomes

Primary

Measure	Time frame
Part 1: Laboratory parameters: standard blood haematology and biochemistry tests, urinalysis; Incidence and severity of Adverse Events with particular focus on Infusion Related Reactions and Infections; Pharmacokinetic profile of NI-0101; Pharmacodynamic effects of NI-0101 by means of ex vivo challenges for the assessment of the MyD88 (e.g. TNF, IL-6) and TRIF (e.g. IFN, IFN* or IP-10) pathways; Immunogenicity of NI-0101, i.e. the presence of anti-NI 0101antibodies. Part 2: Incidence and severity of Adverse Events; Laboratory parameters: standard blood haematology and biochemistry tests, urinalysis; Pharmacokinetic profile of NI-0101; Pharmacodynamic effects of NI-0101 by means of an in vivo LPS challenge by the biomarker assessment of the MyD88 (e.g. TNF, IL-6) and TRIF (e.g. IFN, IFN* or IP-10) pathways; Effects of NI-0101 on the LPS induced inflammation and systemic response (e.g. body temperature, CRP). Immunogenicity of NI-0101, i.e. the presence of anti-NI 0101antibodies.	—

Measure

Time frame

Part 1: Laboratory parameters: standard blood haematology and biochemistry tests, urinalysis; Incidence and severity of Adverse Events with particular focus on Infusion Related Reactions and Infections; Pharmacokinetic profile of NI-0101; Pharmacodynamic effects of NI-0101 by means of ex vivo challenges for the assessment of the MyD88 (e.g. TNF*, IL-6) and TRIF (e.g. IFN*, IFN* or IP-10) pathways; Immunogenicity of NI-0101, i.e. the presence of anti-NI 0101antibodies. Part 2: Incidence and severity of Adverse Events; Laboratory parameters: standard blood haematology and biochemistry tests, urinalysis; Pharmacokinetic profile of NI-0101; Pharmacodynamic effects of NI-0101 by means of an in vivo LPS challenge by the biomarker assessment of the MyD88 (e.g. TNF*, IL-6) and TRIF (e.g. IFN*, IFN* or IP-10) pathways; Effects of NI-0101 on the LPS induced inflammation and systemic response (e.g. body temperature, CRP). Immunogenicity of NI-0101, i.e. the presence of anti-NI 0101antibodies.

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Secondary

Measure	Time frame
N.A.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)