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

NCT ID: NCT06727396

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-14
• Study Completion Date: 2025-05-31

Brief Summary

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CKD-508 dose level 1

Multiple dose of CKD-508 tablets

Group Type: EXPERIMENTAL

CKD-508 Tablet

Intervention Type: DRUG

Investigational drug

CKD-508 dose level 2

Multiple dose of CKD-508 tablets

Group Type: EXPERIMENTAL

CKD-508 Tablet

Intervention Type: DRUG

Investigational drug

CKD-508 dose level 3

Multiple dose of CKD-508 tablets

Group Type: EXPERIMENTAL

CKD-508 Tablet

Intervention Type: DRUG

Investigational drug

CKD-508 dose level 4

Multiple dose of CKD-508 tablets

Group Type: EXPERIMENTAL

CKD-508 Tablet

Intervention Type: DRUG

Investigational drug

Placebo

Multiple dose of placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type: DRUG

Placebo

Interventions

CKD-508 Tablet

Investigational drug

Intervention Type: DRUG

Placebo Tablet

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Glendale, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Sophie Lee

Role: primary

Other Identifiers

A104_02PK2405

Identifier Type: -

Identifier Source: org_study_id