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

Trial Summary

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.

What is the purpose of this trial?

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

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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