First in Human Study of NI-0701 in Healthy Volunteers

NCT ID: NCT01255501

Last Updated: 2010-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Study Groups

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NI-0701

Group Type EXPERIMENTAL

NI-0701

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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NI-0701

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Light Chain Bioscience - Novimmune SA

INDUSTRY

Sponsor Role lead

Principal Investigators

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John Lambert, MD

Role: PRINCIPAL_INVESTIGATOR

PXL

Locations

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London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NI-0701-01

Identifier Type: -

Identifier Source: org_study_id