CP1050-E101 SAD & MAD in healthy volunteers
Research type
Research Study
Full title
A randomised, first-in-human, double-blinded, placebo-controlled study to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CP1050 in healthy subjects; including the effect of food and gender on the pharmacokinetics and pharmacodynamics of a single dose of CP1050 in healthy subjects
IRAS ID
237486
Contact name
Jim Bush
Contact email
Sponsor organisation
Curadim Pharma Co Ltd
Eudract number
2017-004470-34
Duration of Study in the UK
0 years, 6 months, 27 days
Research summary
CP1050 is a drug being developed to treat a range of autoimmune-mediated diseases. CP1050 acts on a receptor called the Sphingosine 1-Phosphate (S1P) receptor, which regulates a broad number of cellular activities that keep cells functioning as well as playing a role in lymphocyte movement and helping to direct other immune system cells.
CP1050 is expected to reduce the number of lymphocytes in the blood thus helping control various immune mediated inflammatory diseases.
Another S1P receptor modulator is already approved for multiple sclerosis; however, this drug has an effect of slowing the heart rate after the first dose. It is hoped that CP1050 will provide the effects of managing the immune system without the cardiac side effects.CP1050 has never been tested in humans. The aim of this study is to collect safety and tolerability data on CP1050.
The study will have 4 stages.
Part 1:- 7 groups of 10 males will be given one dose of study drug; 8 will receive CP1050 and 2 will receive placebo in the fasted state. The stay will be from Day -2 to Day 3.
Part 2:- One group from part 1 will return for part 2 to evaluate the effect of food. They will receive a second single dose of the study drug (8 will receive CP1050 and 2 placebo). The stay will be from Day -1 to Day 3.
Part 3:- One group of 10 females will be given one dose of study drug; 8 will receive CP1050 and 2 will receive placebo in the fasted state. The stay will be from Day -2 to Day 3.
Part 4:- 3 groups of 12 subjects will receive multiple doses of study drug (10 CP1050 and 2 placebo). Each will reside in the unit from Day -2 to Day 23.REC name
North East - York Research Ethics Committee
REC reference
18/NE/0001
Date of REC Opinion
17 Jan 2018
REC opinion
Favourable Opinion