NCT01244607

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

First QC Date

November 16, 2010

Last Update Submit

November 18, 2010

Conditions

Allergic Contact Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Effect of NI-0801 administration on the severity of the cutaneous response to Nickel challenge as measured using the score system of the DKG (Deutsche Kontakt-Allergie Gruppe).

Secondary Outcomes (1)

  • Safety and tolerability of NI-0801 as measured by the incidence and severity of treatment emergent adverse events.

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

NI-0801

EXPERIMENTAL
Drug: NI-0801

Interventions

PlaceboDRUG

single i.v. administration

Placebo
NI-0801DRUG

single i.v. administration

NI-0801

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Dermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 19, 2010

Last Updated

November 19, 2010

Record last verified: 2010-11