Clinical trial NCT06727396: A Study to Investigate the Safety, Tolerability, PK, and PD of CKD-508 in Healthy Participants
Official title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Single Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CKD-508 in Healthy Participants.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 1, randomized, parallel-group, placebo-controlled, double-blinded study aims to evaluate the safety, PK, and PD of CKD-508 when administered multiple times once daily to healthy participants.


Eligibility criteria: Inclusion Criteria:

* The participant is capable of providing signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
* Male and female adults aged 18 to 55 years at screening.
* Healthy participants were determined by pre-study medical evaluation and judged by the Investigator.
* Female participants of non-childbearing potential (surgically sterile \[hysterectomy or oophorectomy\]) or postmenopausal (amenorrhea for more than 12 months with follicle-stimulating hormone \[FSH\] in the postmenopausal range as confirmed by an FSH test).
* Female participants of childbearing potential who agree to use highly effective method of contraception in the protocol consistently and correctly from screening until the last dose administration of the study intervention.
* Male participants must be unable to procreate (defined as surgically sterile \[had a vasectomy\] ≥6 months prior screening) or must agree to use a highly effective contraception as detailed in the protocol during the intervention period and for at least 90 days after the study completion and refrain from donating sperm during this period.
* Non-smoker (or other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (\<200 ng/mL) at screening and admission.

Exclusion Criteria:

* History or evidence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder as determined by the Investigator.
* Presence of any disorder that would interfere with the absorption, distribution, metabolism, or excretion of study intervention as judged by the Investigator.
* Serum alkaline phosphatase (ALP) or total bilirubin ≥upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>ULN at either screening or admission.
* Abnormal renal function with estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73 m2 at screening.
* History or presence of clinically significant abnormal cardiac automaticity, heart rhythm, ECG findings, or other relevant conditions that may pose a risk to the participants as judged by the Investigator.
* History of alcohol and/or illicit drug abuse within 2 years before screening or positive urine test for alcohol or positive urine drug test at screening or admission.
* Positive test for HBsAg, HCV RNA, or HIV antibody at screening.
* Currently taking a lipid-modifying medication.
* History of hypersensitivity to CKD-508 or medicinal products with similar chemical structures.
* Individual unlikely to comply with the protocol requirements, instructions, and study-related restrictions.

Primary outcomes:
measure: Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)
timeFrame: up to Day 56
measure: Maximum Plasma Concentrations of CKD-508 after single and multiple doses
timeFrame: up to Day 56
measure: Time to Maximum Plasma Concentrations of CKD-508 after single and multiple doses
timeFrame: up to Day 56
measure: Area Under the Concentration-Time Curve of CKD-508 after single dose
timeFrame: up to 24 hours post-dose
measure: Area Under the Concentration-Time Curve of CKD-508 after multiple doses
timeFrame: up to Day 56
measure: Change from baseline in CETP activity after multiple doses of CKD-508 or placebo
timeFrame: up to Day 56
Secondary outcomes:
measure: Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) after multiple doses of CKD-508 or placebo
timeFrame: up to Day 40
measure: Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) after multiple doses of CKD-508 or placebo
timeFrame: up to Day 40
measure: Change from Baseline in CETP mass after multiple doses of CKD-508 or placebo
timeFrame: up to Day 56
measure: The effects on the cardiac repolarization by assessing the QTc interval after single and multiple doses of CKD-508 or placebo
timeFrame: up to Day 56
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
Study officials:
References: