SAD/MAD Safety and PK Study of RBN-3143 in Healthy and Atopic Dermatitis Subjects
Status:
Not yet recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
RBN-3143 Background: PARP proteins are members of a family of seventeen
ADP-ribosyltransferase (ART) enzymes that regulate cellular processes including gene
expression, protein degradation, and multiple cellular stress responses. RBN-3143 is a
PARP-14 inhibitor. PARP14 is over-expressed in tissues with inflammatory diseases. RBN-3143
is a novel, orally administered PARP14 inhibitor that was developed to be evaluated as
therapy for a range of inflammatory diseases, with an initial focus on Atopic Dermatitis.
Study Overview: The study consists of 2 parts. Part A: This part of the study will be
conducted in a clinical research unit (CRU) and will enroll healthy adult subjects to
determine the safety of RBN-3143; its absorption, metabolism, and excretion (what the body
does to this drug); and will assess its potential pharmacodynamic properties (what the drug
does to the body).
There are 3 subsections to this part of the study. The first segment will be conducted in a
double-blind manner (neither the investigator nor subject will know if placebo or RBN-3143is
given) and will assess RBN-3143 when taken in a fasted state (before food) as either a single
dose or twice daily dose. The last two segments will be Open Label (all subjects will receive
RBN-3143) and will assess RBN-3143 when taken with food, with pantoprazole (optionally), a
medication that decreases the amount of acid in the stomach, and with midazolam
Part B: After completion of Part A, the second part of the study will be conducted in
patients with moderate to severe atopic dermatitis and Part B details will be included at
that time.