Investigating CKD-508 in healthy adults
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 study is testing a new drug called CKD-508 in healthy adults to see how it works in the body and if it's safe to use.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Chong Kun Dang Pharmaceutical Industry-sponsored |
| Locations | 1 site (Glendale, California) |
| Trial ID | NCT06727396 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of CKD-508, administered multiple times daily to healthy participants. The study is randomized, placebo-controlled, and double-blinded, ensuring that neither the participants nor the researchers know who receives the active treatment or placebo. The aim is to gather data on how the drug behaves in the body and its potential effects on healthy individuals.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 55 who meet specific inclusion criteria.
Not a fit: Patients with underlying health conditions or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and effects of CKD-508, potentially leading to its use in future treatments.
How similar studies have performed: While this approach is common in early-phase trials, the specific drug CKD-508 has not been previously tested in this manner.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Glendale, California
- Research Site — Glendale, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.