RADAR

RBN-3143 is being developed for the treatment of atopic dermatitis. Atopic dermatitis (also known as eczema) is a condition that causes dry, itchy, and inflamed skin and is the most common inflammatory skin condition worldwide. It is common in young children (occurring in approximately 15% of children and 9% of adolescents) but can occur at any age and affects approximately one in three New Zealanders. Eczema is caused by a combination of immune system activation, genetics, environmental factors, and stress.

RBN-3143 works by inhibiting (slowing down or stopping) the process of a protein called PARP14. PARP14 has a role to play with inflammation in certain skin conditions such as eczema. Previous animal studies have shown that by reducing the activity of PARP14, the inflammatory changes to the skin are reduced. It is hoped that, by reducing the reducing the activity of PARP14, RBN-3143 may be an effective treatment for eczema.

This part of the study is called a ‘drug-drug interaction’ (DDI) study. CYP3A is a family of genes which produce specific enzymes (proteins that are involved with reactions inside your body). The CYP3A enzymes are involved in breaking down many types of drugs, such as midazolam. There is the potential that RBN-3143 has an effect on CYP3A in the body.

This part of the study investigates the effect of RBN-3143 on CYP3A when take with midazolam. Midazolam is a type of sedative and is an approved drug in New Zealand.

The purpose of this Part A – DDI study is to:

• Evaluate how safe and well tolerated RBN-3143 is, in healthy participants.
• Measure levels of RBN-3143 in the blood over time, following dosing with RBN-3143 (pharmacokinetics/PK)
• Compare exposure of midazolam, with or without RBN-3143

• Assess the effects of RBN-3143 on an ECG (Electrocardiograms that measure the electrical activity of your heart)

Study Visits: 18-night stay + 2 visits

Reimbursement: $8300 (less tax)