CKD-508 in Healthy Volunteers

Overseen By David Han, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Chong Kun Dang Pharmaceutical

Must not be taking: Lipid-modifying

Disqualifiers: Cardiovascular, Renal, Psychiatric, Drug abuse, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and behavior of a new drug, CKD-508, in the body when taken by healthy individuals. The study divides participants into groups to receive different doses of the drug or a placebo (a pill with no active medicine) to observe their body's reactions. Healthy adults who haven't used tobacco in the past six months and don't have serious medical conditions might be suitable candidates. The goal is to gather information about the drug's safety and effects before testing it in individuals with specific health conditions. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking a lipid-modifying medication.

Is there any evidence suggesting that CKD-508 is likely to be safe for humans?

Research has shown that CKD-508 is a new drug designed to protect the heart. The studies aim to demonstrate that this drug works without the negative side effects seen in similar drugs. The current trial is in its early phase, focusing on whether the treatment is safe and well-tolerated by healthy volunteers.

Earlier research monitored short-term side effects, meaning researchers are closely watching for any that might occur. Although specific safety details are still being gathered, the main goal of this early phase is to ensure the drug's safety for humans. CKD-508 would not have reached this stage if it had serious or frequent side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CKD-508 is unique because it offers a new approach to treating chronic kidney disease (CKD). While most current treatments focus on managing symptoms or controlling blood pressure, CKD-508 targets the underlying pathways involved in kidney function. This drug is being tested in multiple dose levels, which could help determine the most effective regimen. Researchers are excited about CKD-508 because it has the potential to improve kidney health directly, offering hope for more effective management of CKD.

What evidence suggests that CKD-508 could be effective?

CKD-508 is a new treatment under investigation to assess its effects on the body. Currently, limited information exists on its efficacy for specific health issues. Researchers are examining the drug's behavior in the body, its safety, and interactions with other medications. The primary goal is to understand its safety and pharmacokinetics. This trial includes various treatment arms, each testing a different dose level of CKD-508 on healthy participants, along with a placebo arm. Early tests are evaluating these doses to observe their effects. Further studies will be necessary to determine if CKD-508 effectively treats any medical conditions. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This clinical trial is for healthy individuals who want to participate in a study testing the safety of a new medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and cannot have conditions that would interfere with the study.

Inclusion Criteria

Healthy participants determined by pre-study medical evaluation and judgment by the Investigator

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

I am a woman who cannot have children due to surgery or menopause.

Exclusion Criteria

Individual unlikely to comply with the protocol requirements, instructions, and study-related restrictions

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

I don't have conditions that affect how my body handles medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of CKD-508 or placebo tablets daily

8 weeks

Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CKD-508

Trial Overview The trial is testing CKD-508, a new tablet, against a placebo (a pill with no active drug). It's designed to see how safe CKD-508 is and how it affects the body (pharmacokinetics) and what it does in the body (pharmacodynamics) when taken daily.

How Is the Trial Designed?

Group I: CKD-508 dose level 4 Experimental Treatment 1 Intervention

Multiple dose of CKD-508 tablets

Group II: CKD-508 dose level 3 Experimental Treatment 1 Intervention

Multiple dose of CKD-508 tablets

Group III: CKD-508 dose level 2 Experimental Treatment 1 Intervention

Multiple dose of CKD-508 tablets

Group IV: CKD-508 dose level 1 Experimental Treatment 1 Intervention

Multiple dose of CKD-508 tablets

Group V: Placebo Placebo Group 1 Intervention

Multiple dose of placebo tablets

Who Is Running the Clinical Trial?

Chong Kun Dang Pharmaceutical

Lead Sponsor

Trials

292

Recruited

66,500+

Founded

1941

Headquarters

Seoul, South Korea

Known For

Biotechnology innovations

Top Products

Duvie, Camtobel, Belloxa, Gemtan

Young-Joo Kim

Chong Kun Dang Pharmaceutical

Chief Medical Officer since 2021

MD

Choi Hee-nam

Chong Kun Dang Pharmaceutical

Chief Executive Officer since 2024

Economics at Hanyang University; PhD in Economics, University of Pittsburgh

Citations

1. withpower.com withpower.com/trial/ckd-508-in-healthy-volunteers-21d9e

CKD-508 in Healthy Volunteers 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06979973

Study Details | NCT06979973 | A Drug-drug Interaction ... A Drug-drug Interaction Study to Investigate the Pharmacokinetic Interactions Between CKD-508, Midazolam, and Rosuvastatin in Healthy Adult Male Participants.

3. ctv.veeva.com ctv.veeva.com/study/a-study-to-investigate-the-safety-tolerability-pk-and-pd-of-ckd-508-in-healthy-participants

A Study to Investigate the Safety, Tolerability, PK, and PD of ... This Phase 1, randomized, parallel-group, placebo-controlled, double-blinded study aims to evaluate the safety, PK, and PD of CKD-508 when ...

4. reporter.nih.gov reporter.nih.gov/project-details/11081703

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

5. ichgcp.net ichgcp.net/clinical-trials-registry/NCT04488900

Clinical Trial on CKD-508 Capsule, CKD-508 Tablet - ICH GCP The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in ...

6. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/a-sad-mad-fe-safety-pk-pd-study-of-ckd-508-in-healthy-subjects/

A SAD, MAD, FE, Safety, PK & PD study of CKD-508 in ... 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 ...

7. atherosclerosis-journal.com atherosclerosis-journal.com/article/S0021-9150(20)31395-2/abstract

Old target, but new drug: 2nd generation cetp inhibitor ... The aim of this study was to examine the therapeutic effect of CKD-508, an orally available CETP inhibitor with improved efficacy and safety. ... data mining, AI ...