New drug CKD-508 tested for safety in healthy people
NCT ID NCT06727396
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested the safety and how the body handles CKD-508, a new drug, in 44 healthy adults. Participants received either the drug or a placebo once daily. The study measured side effects, drug levels in the blood, and changes in cholesterol-related markers. Since this is a Phase 1 study in healthy people, it does not aim to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CKD-508 tablet
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
44 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
-
Jun 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Glendale, California, 91206, United States
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