Safety and Efficacy Study of Topically Administered DS109 Cream
Research type
Research Study
Full title
A Randomised, Double Blind, Vehicle Controlled, Multiple Ascending Dose Study to Investigate the Safety and Local Tolerability of DS109 Cream in Healthy Volunteers.
IRAS ID
214805
Contact name
Blanaid Ni Chuinneagain
Contact email
Sponsor organisation
DS Biopharma
Eudract number
2016-000094-21
Duration of Study in the UK
0 years, 2 months, 0 days
Research summary
This is a Phase I healthy volunteer first-in-man dose-escalation study to evaluate the tolerability of two doses of DS109, a topical cream which is being developed for the treatment of inflammatory skin conditions. \n\nIt is a randomised, double-blind, vehicle-controlled study in male and female volunteers aged 18 to 45. Twelve volunteers will be enrolled with at least 6 in each of two sequential cohorts. Volunteers will be randomised to receive either the active cream on one forearm and the vehicle (placebo) cream on the other forearm, or vehicle cream on both forearms. Active or vehicle cream will be administered for a 50 cm2 area of skin on each forearm twice a day for 14 days.\n\nThe two cohorts will evaluate 1%, and 5% DS109 cream, respectively and a matched vehicle cream.\n\nThe blinded study treatment will be labelled with right and left arm to ensure the study drug is always applied to the correct forearm according to the randomisation.\n\nVolunteers will make twice-daily visits for 14 days to the clinical unit to receive study treatment and undergo clinical assessments. Local tolerability (before study drug administration on Days 1 to 14) will be assessed for any observed skin reactions. This will also be carried out on the morning of Day 15. No overnight stays are required.\n\nCohorts will be in a sequential manner starting with the cohort evaluating 1% DS109 cream and a matched vehicle cream. The decision to increase the dose administered and to commence the subsequent cohort will be made by a Safety Monitoring Committee (SMC). Following the initial cohort, the dose to be administered in each subsequent cohort may be repeated or reduced based upon SMC recommendation.\n\nThe study duration for each subject will be approximately 8 weeks including screening and follow-up visits for both cohorts.\n
REC name
HSC REC A
REC reference
16/NI/0193
Date of REC Opinion
4 Oct 2016
REC opinion
Further Information Favourable Opinion