RECRUITING

A Study to Investigate the Safety, Tolerability, PK, and PD of CKD-508 in Healthy Participants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2024-11-14

Study Completion:2025-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06727396

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

David Han, MD

CONTACT

747-297-9023

david.han@cctrials.com

Study Locations (Sites)

Research Site

Glendale, California, 91206

United States

Collaborators and Investigators

Sponsor: Chong Kun Dang Pharmaceutical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-14

Study Completion Date2025-05

Study Record Updates

Study Start Date2024-11-14

Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

Healthy Subjects