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NI-0801 in Allergic Contact Dermatitis

NCT ID: NCT01244607

Last Updated: 2010-11-19

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

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of the study is to assess the effect of a single dose of NI-0801 on the severity of nickel-induced allergic contact dermatitis.

Detailed Description

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Conditions

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Allergic Contact Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single i.v. administration

NI-0801

Group Type EXPERIMENTAL

NI-0801

Intervention Type DRUG

single i.v. administration

Interventions

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Placebo

single i.v. administration

Intervention Type DRUG

NI-0801

single i.v. administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged ≥ 18 and ≤ 70 years
* Either male or a female lacking childbearing potential
* Previously documented nickel allergy

Exclusion Criteria

* Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial or that would prevent subjects from providing informed consent.
* Known or previous diagnosis of malignancy
* Known current active tuberculosis or a history of active TB within 12 months of screening
* Known infection with HIV, Hepatitis B or C
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Light Chain Bioscience - Novimmune SA

INDUSTRY

Sponsor Role lead

Other Identifiers

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NI-0801-02

Identifier Type: -

Identifier Source: org_study_id