A FIH study to evaluate the effects of SDC-1801 in healthy adults or with plaque psoriasis
Research type
Research Study
Full title
A First-in-human, Phase I, Randomised, Single Centre 4-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Food Effects, and Pharmacodynamics of Single Ascending and Multiple Ascending Oral Doses of SDC-1801 in Healthy Adults or Adults with Plaque Psoriasis
IRAS ID
1006137
Contact name
John Reader
Contact email
Sponsor organisation
Sareum Limited
Research summary
The aim of this clinical study, conducted in healthy volunteers and plaque psoriasis patients, is to investigate the safety, tolerability and effects of food on a medicine called SDC-1801, being developed as a treatment for plaque psoriasis, a skin disease.
This study will be conducted at a single site in England, and has four parts.
In parts 1, 2 and 4, participants will receive either SDC-1801, or a matching dummy medicine called a placebo, and neither they nor the investigators will know which treatment they are receiving.
In part 1, healthy volunteers assigned to different cohorts (groups) will be given either SDC-1801 or placebo, at different doses. The first cohort will be given the lowest dose, 5mg. Blood samples will be taken from participants to measure the levels of SDC-1801. The next cohort will only receive their dose of SDC-1801 if assessments by the Safety Review Committee (SRC) from the previous cohort show that the drug was safe. Each participant will be given one dose of the study drug or placebo.
Part 2 of the study will only start after sufficient results are available from part 1. Healthy volunteers in different cohorts will be given either SDC-1801 or placebo once or twice daily for 10 days. The first cohort will receive a dose not greater than 75mg of SDC-1801.
In part 3, healthy volunteers will be assigned to two different groups. The first group will receive a dose of SDC-1801 after breakfast on the first day of the study. They will be monitored for 6 days. Then, after another 7 days, they will receive a dose of SDC-1801 following an overnight fast (going without food) of at least 10 hours. The second group will receive their first dose after an overnight fast, then the second dose after breakfast.
In part 4, patients with plaque psoriasis will be given either SDC-1801 or placebo once or twice daily for 14 days. Patients will be split into 2 groups, and each group will receive a different dose of SDC-1801 or placebo.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0272
Date of REC Opinion
9 Nov 2022
REC opinion
Further Information Unfavourable Opinion