Status:
COMPLETED
First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers
Lead Sponsor:
Light Chain Bioscience - Novimmune SA
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01808469
Start Date
November 1 2012
End Date
March 1 2014
Last Update
October 24 2014
Active Locations (1)
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1
Centre for Human Drug Research
Leiden, Netherlands, 2333 CL