NI-0801 in Allergic Contact Dermatitis

Light Chain Bioscience

Status and phase: Completed; Phase 1

Conditions: Allergic Contact Dermatitis

Treatments: Drug: NI-0801; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01244607

NI-0801-02

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

22 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

NI-0801

Experimental group

Treatment:

Drug: NI-0801