First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers
NI-0101-01
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.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Nov 2012
Longer than P75 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 18, 2013
CompletedFirst Posted
Study publicly available on registry
March 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedOctober 24, 2014
October 1, 2014
1.3 years
February 18, 2013
October 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 8 weeks
Secondary Outcomes (2)
Pharmacokinetic parameters of NI-0101
Up to 8 weeks
Pharmacodynamic parameters of NI-0101
Up to 8 weeks
Study Arms (2)
NI-0101
EXPERIMENTALNI-0101 is an anti-Toll-like receptor monoclonal antibody.
Placebo
PLACEBO COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Human Drug Research
Leiden, 2333 CL, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Koos Prof. Burggraaf, MD, Ph
Centre for Human Drug Research, Leiden, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2013
First Posted
March 11, 2013
Study Start
November 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
October 24, 2014
Record last verified: 2014-10