First in Human Study of NI-0701 in Healthy Volunteers

December 6, 2010 updated by: Light Chain Bioscience - Novimmune SA

A First in Man Randomized Placebo Controlled Study of Single Ascending Intravenous Doses of NI-0701 in Healthy Volunteers

The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Non smokers
  • Able to adhere to study visits and protocol requirements

Exclusion Criteria:

  • Any clinical safety laboratory measurements value > Grade 1 on WHO Toxicity Scale
  • Established or recurrent history of allergic reactions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
EXPERIMENTAL: NI-0701
Drug: NI-0701

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers

Secondary Outcome Measures

Outcome Measure
NI-0701 Pharmacokinetic parameters in healthy volunteers
NI-0701 plasma pharmacodynamic effects upon NI-0701 single intravenous infusion
Pharmacodynamic effects of NI-0701 on Histamine skin-induced wheal and flare
Immunogenicity of NI-0701

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Light Chain Bioscience - Novimmune SA

Investigators

  • Principal Investigator: John Lambert, MD, PXL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (ESTIMATE)

December 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 7, 2010

Last Update Submitted That Met QC Criteria

December 6, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • NI-0701-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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