Healthy SubjectsPhase 1NCT06727396
A Study to Investigate the Safety, Tolerability, PK, and PD of CKD-508 in Healthy Participants
A Phase 1 study testing CKD-508 Tablet in people with Healthy Subjects, run by Chong Kun Dang Pharmaceutical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- CKD-508 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2024to 5 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- CKD-508 Tablet, Placebo Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-508 TabletDrug
Investigational drug
Placebo TabletDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CKD-508 dose level 1 | Experimental | Multiple dose of CKD-508 tablets Receives: Drug: CKD-508 Tablet |
| CKD-508 dose level 2 | Experimental | Multiple dose of CKD-508 tablets Receives: Drug: CKD-508 Tablet |
| CKD-508 dose level 3 | Experimental | Multiple dose of CKD-508 tablets Receives: Drug: CKD-508 Tablet |
| CKD-508 dose level 4 | Experimental | Multiple dose of CKD-508 tablets Receives: Drug: CKD-508 Tablet |
| Placebo | Placebo comparator | Multiple dose of placebo tablets Receives: Drug: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to Day 56
Maximum Plasma Concentrations of CKD-508 after single and multiple doses
Peak plasma concentration (Cmax)
Measured: up to Day 56
Time to Maximum Plasma Concentrations of CKD-508 after single and multiple doses
Time of peak plasma concentration (Tmax)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
The absolute values and percentages of change from baseline in LDL-C measured in blood after multiple doses of CKD-508 or placebo
Measured: up to Day 40
Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) after multiple doses of CKD-508 or placebo
The absolute values and percentages of change from baseline in HDL-C measured in blood after multiple doses of CKD-508 or placebo
Measured: up to Day 40
Change from Baseline in CETP mass after multiple doses of CKD-508 or placebo
The absolute values and percentages of change from baseline in CETP protein concentration measured in blood after multiple doses of CKD-508 or placebo
Measured: 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
Measured: up to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start14 Nov 2024
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727396
- Sponsor's protocol ID
- A104_02PK2405
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06727396
- Acronym / sponsor ID
- A104_02PK2405
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CKD-508 dose level 1 | Experimental | Drug: CKD-508 TabletMultiple dose of CKD-508 tablets |
| CKD-508 dose level 2 | Experimental | Drug: CKD-508 TabletMultiple dose of CKD-508 tablets |
| CKD-508 dose level 3 | Experimental | Drug: CKD-508 TabletMultiple dose of CKD-508 tablets |
| CKD-508 dose level 4 | Experimental | Drug: CKD-508 TabletMultiple dose of CKD-508 tablets |
| Placebo | Placebo comparator | Drug: Placebo TabletMultiple dose of placebo tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD-508 TabletInvestigational drug | Drug | CKD-508 dose level 1, CKD-508 dose level 2, CKD-508 dose level 3, CKD-508 dose level 4 |
| Placebo TabletPlacebo | Drug | Placebo |
Primary outcome
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)
Time frame: up to Day 56
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.
Maximum Plasma Concentrations of CKD-508 after single and multiple doses
Time frame: up to Day 56
Peak plasma concentration (Cmax)
Time to Maximum Plasma Concentrations of CKD-508 after single and multiple doses
Time frame: up to Day 56
Time of peak plasma concentration (Tmax)
Area Under the Concentration-Time Curve of CKD-508 after single dose
Time frame: up to 24 hours post-dose
Area under the concentration-time curve from pre-dose (time 0) to post-dose 24 h (AUC0-24h) after a single dose
Area Under the Concentration-Time Curve of CKD-508 after multiple doses
Time frame: up to Day 56
Area under the concentration-time curve from pre-dose (time 0) to post-dose 24 h (AUCtau.ss) after multiple doses
Change from baseline in CETP activity after multiple doses of CKD-508 or placebo
Time frame: up to Day 56
The absolute values and percentages of change from baseline in CETP activity measured in blood after multiple doses of CKD-508 or placebo
4 secondary outcomes
Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) after multiple doses of CKD-508 or placebo
Time frame: up to Day 40
Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) after multiple doses of CKD-508 or placebo
Time frame: up to Day 40
Change from Baseline in CETP mass after multiple doses of CKD-508 or placebo
Time frame: 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
Time frame: up to Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-508 Tablet in people with Healthy Subjects, run by Chong Kun Dang Pharmaceutical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) (time frame: up to Day 56). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.