A SAD, MAD, FE, Safety, PK & PD study of CKD-508 in Healthy Subjects
Research type
Research Study
Full title
A Phase 1, First-in-Human, Double-blind, Randomized, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics and Food Effect of CKD-508 after Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects
IRAS ID
279847
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
Chong Kun Dang Pharmaceutical Corp.
Eudract number
2020-001436-99
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 28 days
Research summary
This is a randomised, double-blind, placebo controlled, single-centre, three-part study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple oral doses of CKD-508, as well as the food-effect, in healthy adult male and female subjects. Females must be of non-childbearing potential.
CKD-508 is being developed by Chong Kun Dang Pharmaceutical Corp. for treatment of raised cholesterol (dyslipidaemia). Research has shown that “bad cholesterol” (LDL-C) is very likely to add to development of coronary heart disease, whilst “good cholesterol” (HDL-C) lowers the risk. The study drug, CKD-508 belongs to a new class of medication that is thought to both decrease LDL-C and increase HDL-C levels. It is thought for CKD-508 to provide modest heart protection without having the negative side effects that were seen with other drugs in the same medication class, and thereby addressing patient needs for effective treatment.
This is a first-in-human clinical trial. The main purpose of the study is to see how safe CKD-508 is and how well the body tolerates CKD-508 after single and repeated oral doses. The study will also investigate how CKD-508 is taken up into the body, chemically broken down, distributed through the body, and excreted from the body under fasted and fed conditions (overall referred to as PK), and the effects of CKD-508 on the body (referred to as PD) using electrocardiograms (ECGs), biomarkers and blood lipid tests. No genetic samples will be collected.
The three study parts are: Part 1 single rising dose, Part 2 an assessment of food-effect (single doses) and Part 3 multiple rising doses (once daily). Subjects will be screened for enrolment in Parts 1 or 3. All study parts will include an in-house treatment period, out-patient visits and a final follow-up visit. Selected subjects from Part 1 will participate in Part 2 after a washout period of 2 weeks for investigation of the food-effect. Sentinel dosing applies to all cohorts in Parts 1 and 3. Approximately 72 subjects may participate in the study.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0058
Date of REC Opinion
1 Jun 2020
REC opinion
Further Information Favourable Opinion