A Study to Investigate the Safety, Tolerability, PK, and PD of CKD-508 in Healthy Participants

NCT06727396 | Completed Phase 1 FDA Drug

• 1 other identifier: A104_02PK2405
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (6)

• Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE will be defined as any AE that emerges during treatment (i.e., AE which starts during or after study drug administration or pre-existed and worsened in severity after study drug administration), and those will be analyzed for the purpose of safety analysis. The number of participants who experience a TEAE will be reported.

  up to Day 56

• Maximum Plasma Concentrations of CKD-508 after single and multiple doses

  Peak plasma concentration (Cmax)

  up to Day 56

• Time to Maximum Plasma Concentrations of CKD-508 after single and multiple doses

  Time of peak plasma concentration (Tmax)

  up to Day 56

• Area Under the Concentration-Time Curve of CKD-508 after single dose

  Area under the concentration-time curve from pre-dose (time 0) to post-dose 24 h (AUC0-24h) after a single dose

  up to 24 hours post-dose

• Area Under the Concentration-Time Curve of CKD-508 after multiple doses

  Area under the concentration-time curve from pre-dose (time 0) to post-dose 24 h (AUCtau.ss) after multiple doses

  up to Day 56

• Change from baseline in CETP activity after multiple doses of CKD-508 or placebo

  The absolute values and percentages of change from baseline in CETP activity measured in blood after multiple doses of CKD-508 or placebo

  up to Day 56

Secondary Outcomes (4)

• Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) after multiple doses of CKD-508 or placebo

  up to Day 40

• Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) after multiple doses of CKD-508 or placebo

  up to Day 40

• Change from Baseline in CETP mass after multiple doses of CKD-508 or placebo

  up to Day 56

• The effects on the cardiac repolarization by assessing the QTc interval after single and multiple doses of CKD-508 or placebo

  up to Day 56

Study Arms (5)

CKD-508 dose level 1

EXPERIMENTAL

Multiple dose of CKD-508 tablets

Drug: CKD-508 Tablet

CKD-508 dose level 2

EXPERIMENTAL

Multiple dose of CKD-508 tablets

Drug: CKD-508 Tablet

CKD-508 dose level 3

EXPERIMENTAL

Multiple dose of CKD-508 tablets

Drug: CKD-508 Tablet

CKD-508 dose level 4

EXPERIMENTAL

Multiple dose of CKD-508 tablets

Drug: CKD-508 Tablet

Placebo

PLACEBO COMPARATOR

Multiple dose of placebo tablets

Drug: Placebo Tablet

Interventions

CKD-508 Tablet DRUG

Investigational drug

CKD-508 dose level 1; CKD-508 dose level 2; CKD-508 dose level 3; CKD-508 dose level 4

Placebo Tablet DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Research Site

Glendale, California, 91206, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 10, 2024
• Study Start: November 14, 2024
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)