Allergic Contact Dermatitis
Conditions
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.
Interventions
DRUGPlacebo
single i.v. administration
DRUGNI-0801
single i.v. administration
Sponsors
Light Chain Bioscience - Novimmune SA
Study design
Allocation
RANDOMIZED
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety and tolerability of NI-0801 as measured by the incidence and severity of treatment emergent adverse events. | — |
Outcome results
None listed