SCION
Research type
Research Study
Full title
A Phase 2, Randomized, 3-Arm Parallel Group, Placebo and Active-Controlled Study of the Effect of PL8177 Administered via Subcutaneous Injection in Healthy Male Volunteers on Inflammatory Onset and Resolution.
IRAS ID
271597
Contact name
Vikas Kapil
Contact email
Sponsor organisation
Palatin Technologies, Inc.
Eudract number
2019-003197-24
Duration of Study in the UK
1 years, 7 months, 4 days
Research summary
Inflammation is the underlying process by which a multitude of diseases occur, ranging from inflammatory bowel disease, to asthma and coronary artery disease. Inflammation is the key process by which our immune cells respond to potential threats. It was once thought of as a purely protective process, however we now know that this is not always the case. Inflammation can be harmful in some cases, particularly when we develop inflammation that causes harm to our own organs and tissues. Whilst there are already treatments for inflammatory diseases, most of these are designed to stop the process of inflammation at its earliest steps. This study will assess a new investigational drug called PL8177. An investigational drug is a medicinal product that has not yet received approval from governmental regulatory authorities for routine use in humans. PL8177 influences inflammation at other key steps in the immune pathway, and therefore may offer an alternative treatment for some inflammatory conditions.
PL8177 is a subcutaneous injection which has been shown to bind with melanocortin receptors. These receptors have important roles in skin colour, but they have also been found to influence inflammatory cells and dampen down the production of inflammatory proteins. We will perform a 3-arm clinical trial in 45 healthy male volunteers. 3 groups, each with 15 volunteers, will be given PL8177, a placebo or a prednisolone tablet. We will induce a small area of localised skin inflammation by placing a blister on the forearm of the volunteers during the 11 day study period, and take peripheral blood samples and fluid samples from the blisters to assess whether PL8177 influences the inflammation in healthy volunteers.
REC name
London - Central Research Ethics Committee
REC reference
20/LO/0191
Date of REC Opinion
6 Mar 2020
REC opinion
Favourable Opinion