NI-0801 in Allergic Contact Dermatitis

Light Chain Bioscience - Novimmune SA22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Enrollment

Conditions

Allergic Contact Dermatitis

Interventions

PlaceboDRUG

single i.v. administration

NI-0801DRUG

single i.v. administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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